Product Specifications
One catheter. Many indications.
The Lotus No-Balloon Catheter is FDA 510(k)-cleared for continuous drainage, continuous bladder irrigation, and intermittent catheterization via urethral, suprapubic, or nephrostomy access.
8–26 Fr
Size Range
3-in-1
Foley · Straight · Malecot
30 Days
Max Indwelling
FDA 510(k) K191512
ISO 11135 Sterilization
ISO 10993 Biocompatible
USP Class VI
Mechanism of Action
Design & function
Drainage Tip
Drainage at tip fully empties the bladder — eliminating residual urine pooling
Deployable Wing
Soft wings reduce bladder neck irritation and replace the inflatable balloon for retention
Flexible Shaft
Soft flexible shaft for patient comfort. Available in silicone, TPU, PVC, and latex
Compressible Handle
Expanding the handle deploys the wings. Compressing it retracts them for safe removal
How It Works
Insert like a Foley. No balloon required.
Same aseptic technique. Same CPT code (51702). Same drainage bags. The only difference is how the catheter stays in place — soft deployable wings instead of an inflatable balloon.
1
Insert
Lubricate and insert the catheter tip into the bladder using standard aseptic technique. Urine flow confirms placement.
2
Deploy
Gently expand the bellows handle to open the Malecot-type wings. The wings hold the catheter in place and open the drainage pathway.
3
Secure
Lock the bellows into the LotusCatheter Stabilizer. Attach the stabilizer pad to the patient's thigh and connect the drainage bag.
4
Remove
For indwelling use, leave the catheter in place for up to 30 days. When ready to remove, compress the bellows to retract the wings. Gently withdraw. No deflation step. No syringe needed.
Minimal training required — clinicians familiar with Foley insertion can use the Lotus catheter with a brief orientation on the bellows mechanism.
Available Configurations
Product specifications
All Lotus catheters use balloon-free wing retention, EO sterilization (ISO 11135; SAL 10⁻⁶), and are packaged 10 units per box, 100 per carton. Available hydrophilic-coated or non-coated (KY jelly sachet-packed). 5-year shelf life.
Male
| French Size | Catalog No. | Outer Diameter | Min. Flow Rate |
|---|---|---|---|
| 14 Fr | LC-M-14 | 4.62 mm | 70 ml/min |
| 16 Fr | LC-M-16 | 5.28 mm | 100 ml/min |
| 18 Fr | LC-M-18 | 5.94 mm | 100 ml/min |
| 20 Fr | LC-M-20 | 6.60 mm | 100 ml/min |
| 22 Fr | LC-M-22 | 7.26 mm | 100 ml/min |
| 24 Fr | LC-M-24 | 7.92 mm | 100 ml/min |
| 26 Fr | LC-M-26 | 8.58 mm | 100 ml/min |
Female
| French Size | Catalog No. | Outer Diameter | Min. Flow Rate |
|---|---|---|---|
| 12 Fr | LC-F-12 | 3.96 mm | 30 ml/min |
| 14 Fr | LC-F-14 | 4.62 mm | 70 ml/min |
| 16 Fr | LC-F-16 | 5.28 mm | 100 ml/min |
| 18 Fr | LC-F-18 | 5.94 mm | 100 ml/min |
Pediatric
| French Size | Catalog No. | Outer Diameter | Min. Flow Rate |
|---|---|---|---|
| 8 Fr | LC-P-8 | 2.64 mm | 10 ml/min |
| 10 Fr | LC-P-10 | 3.30 mm | 15 ml/min |
| 12 Fr | LC-P-12 | 3.96 mm | 30 ml/min |
Also Available
Closed System Kit
LotusCatheter® Closed System Kit
A complete, sterile insertion tray packaged with the Lotus No-Balloon Catheter and all components needed for aseptic catheterization. Available in all catheter sizes.
Lotus No-Balloon Catheter
LotusCatheter Stabilizer
Collection Bag
Nitrile Gloves
Fenestrated Drape
Waterproof Underpad
Povidone-Iodine Swabsticks
Lubricant
Soap Towelette
Hand Sanitizer
Skin Protectant Pad
Specimen Container & Label
LotusCatheter® Stabilizer
Purpose-built securement device that locks the bellows mechanism in the deployed position. Hypoallergenic adhesive pad with 360° rotation cradle to accommodate patient movement. Eliminates accidental displacement without tape or sutures. Included in every Closed System Kit.
Lotus No-Balloon Catheter — Product Specification Sheet
Complete technical specifications, materials, and ordering information
Material Options
Multiple polymers. One platform.
Silicone
100% Medical-Grade Silicone
Premium biocompatibility and patient comfort. The current standard across all Lotus SKUs. Indwelling up to 30 days.
TPU
Thermoplastic Polyurethane
Silicone-grade biocompatibility at a more competitive cost. Not feasible for balloon-based catheters — unique to the Lotus platform.
PVC
Polyvinyl Chloride
Cost-optimized for high-volume and price-sensitive procurement environments.
Latex
Natural Rubber Latex
Based on the original Hakki Urinary Catheter design. Familiar material for established clinical workflows.
Safety Profile
Biocompatibility testing
The Lotus No-Balloon Catheter has completed a full biocompatibility evaluation per ISO 10993-1, tested by TÜV SÜD. All eight required tests for a tissue-contacting, indwelling urological device were passed.
| Test | Standard | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | Complies |
| Sensitization | ISO 10993-10:2010 | Complies |
| Irritation | ISO 10993-10:2010 | Complies |
| Subacute Systemic Toxicity | ISO 10993-11:2017 | Complies |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Complies |
| Implantation | ISO 10993-6:2016 | Complies |
| Material-Mediated Pyrogenicity | ISO 10993-11:2017 | Complies |
| Genotoxicity | ISO 10993-3:2014 | Complies |
Testing conducted by TÜV SÜD Certification and Testing. Full test reports available upon request for regulatory submissions and distributor due diligence.
Regulatory Compliance
Recognized standards
The Lotus No-Balloon Catheter conforms with the following FDA-recognized consensus standards. Complete documentation available for international regulatory submissions.
ISO 14971:2007
Application of Risk Management to Medical Devices
ISO 10993-1:2009
Biological Evaluation — Evaluation and Testing Within a Risk Management Process
ISO 10993-3:2014
Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
ISO 10993-5:2009
Tests for In Vitro Cytotoxicity
ISO 10993-7:2008
Ethylene Oxide Sterilization Residuals
ISO 10993-10:2010
Tests for Irritation and Skin Sensitization
ISO 10993-12:2012
Sample Preparation and Reference Materials
ISO 11135:2014
Sterilization — Ethylene Oxide Requirements for Development, Validation and Routine Control
ISO 11607-1:2006
Packaging for Terminally Sterilized Medical Devices — Materials, Sterile Barrier Systems
ISO 11607-2:2006
Packaging — Validation Requirements for Forming, Sealing and Assembly Processes
ISO 11737-1:2018
Microbiological Methods — Determination of a Population of Microorganisms on Products
ASTM F623-99:2013
Performance Requirements for Foley-Type Catheters (Modified for Balloon-Free Design)
Across All SKUs
Standard features
Balloon-Free Retention
Deployable wings replace the inflatable balloon. No residual urine pooling.
Up to 30-Day Dwell
Select polymers cleared for indwelling use up to 30 days. Regulatory pathways in progress across all material options.
Self-Use Capable
FDA-cleared for patient home use — unlike the Foley catheter.
3-in-1 Functionality
Replaces Foley, Malecot, and straight catheters in a single device.
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