Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teleflexmedical, Inc. · Predicate Candidate Screening
64 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
291 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 | 352 | 0 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 | 755 | 0 |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | 2019-12-06 | 101 | 0 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019-07-01 | 265 | 0 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Ca | Teleflexmedical, Inc. | 2019-05-24 | 303 | 0 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG H | Teleflexmedical, Inc. | 2019-05-08 | 145 | 0 |
| K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018-10-12 | 93 | 0 |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018-08-02 | 290 | 1 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with Thu | Teleflexmedical, Inc. | 2018-02-12 | 151 | 0 |
| K161770 | Rusch Silicone Foley Catheter | Teleflexmedical, Inc. | 2017-05-05 | 311 | 0 |
| K162522 | UltraCath Continuous Nerve block Catheter | Teleflexmedical, Inc. | 2017-03-17 | 189 | 0 |
| K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017-02-24 | 120 | 0 |
| K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017-01-19 | 162 | 2 |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016-11-23 | 89 | 0 |
| K161075 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2016-10-04 | 169 | 0 |
| K153089 | 'cottony' II TAPE, PLEDGETS | Teleflexmedical, Inc. | 2016-08-12 | 291 | 0 |
| K153010 | Hudson RCI AquaPak Sterile Prefilled Nebulizers | Teleflexmedical, Inc. | 2016-07-26 | 286 | 0 |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE | Teleflexmedical, Inc. | 2016-06-16 | 237 | 0 |
| K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM | Teleflexmedical, Inc. | 2016-04-08 | 169 | 0 |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | Teleflexmedical, Inc. | 2015-11-27 | 262 | 0 |
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015-08-26 | 30 | 0 |
| K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015-06-26 | 190 | 0 |
| K142103 | CUFF PILOT, SURE SEAL | Teleflexmedical, Inc. | 2015-05-08 | 280 | 0 |
| K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE S | Teleflexmedical, Inc. | 2015-04-29 | 266 | 1 |
| K141888 | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | 2015-04-15 | 275 | 0 |
| K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | 2015-04-02 | 42 | 0 |
| K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | 2015-02-12 | 69 | 0 |
| K143299 | Percuvance(R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015-01-21 | 65 | 2 |
| K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014-12-19 | 84 | 1 |
| K141214 | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS | Teleflexmedical, Inc. | 2014-12-18 | 220 | 0 |
| K141939 | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECR | Teleflexmedical, Inc. | 2014-11-24 | 130 | 0 |
| K142138 | ISO-GARD MASK | Teleflexmedical, Inc. | 2014-10-30 | 86 | 0 |
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFU | Teleflexmedical, Inc. | 2014-10-23 | 269 | 0 |
| K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SY | Teleflexmedical, Inc. | 2014-10-21 | 267 | 0 |
| K141353 | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR | Teleflexmedical, Inc. | 2014-08-01 | 70 | 0 |
| K133439 | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | 2014-06-16 | 216 | 0 |
| K132415 | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE | Teleflexmedical, Inc. | 2014-06-06 | 308 | 0 |
| K132946 | SOFTECH PLUS ETC02 CANNULA | Teleflexmedical, Inc. | 2014-06-04 | 258 | 0 |
| K133173 | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2014-05-23 | 218 | 0 |
| K132729 | ISO-GARD MASK | Teleflexmedical, Inc. | 2014-01-09 | 128 | 0 |
| K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | Teleflexmedical, Inc. | 2013-10-08 | 70 | 0 |
| K122235 | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2013-09-06 | 407 | 0 |
| K123176 | ISO-GARD CLEARAIR MASK | Teleflexmedical, Inc. | 2013-02-14 | 127 | 0 |
| K130043 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION | Teleflexmedical, Inc. | 2013-02-12 | 35 | 0 |
| K121796 | WECK REUSABLE OBTURATOR | Teleflexmedical, Inc. | 2012-10-11 | 114 | 3 |
| K121380 | WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT | Teleflexmedical, Inc. | 2012-05-25 | 17 | 3 |
| K112554 | TRANSRADIAL ARTERY ACCESS DEVICES | Teleflexmedical, Inc. | 2011-11-18 | 77 | 1 |
| K112456 | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT | Teleflexmedical, Inc. | 2011-10-04 | 40 | 6 |
| K111900 | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | Teleflexmedical, Inc. | 2011-08-17 | 43 | 2 |
| K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC H | Teleflexmedical, Inc. | 2011-06-30 | 70 | 4 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda