510(k) Report

FDA applicant

Teleflexmedical, Inc.

Durham, NC64 decisions1985–202451 recalls

FDA records 64 decisions for Teleflexmedical, Inc. (Durham, NC) from 1985 to 2024: 64 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and BTR (Tube, Tracheal (W/Wo Connector)). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 86 predicates, 15 of them its own earlier devices. 51 recalls are linked to its devices, 22 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Teleflexmedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12008: 12009: 12010: 12011: 52012: 22013: 42014: 122015: 92016: 62017: 42018: 32019: 42023: 12024: 1
2007high 12 (2014) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2026

2011: 12013: 22014: 26, 14 Class I2016: 42017: 82018: 22019: 4, 4 Class I2023: 1, 1 Class I2026 (partial year): 3, 3 Class I
2007high 26 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Teleflexmedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teleflexmedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • BTRTube, Tracheal (W/Wo Connector)5decisions
  • EZLCatheter, Retention Type, Balloon4decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene4decisions
  • CAFNebulizer (Direct Patient Interface)4decisions
  • DYBIntroducer, Catheter4decisions

Also: CBN (3), CAC (3), DQX (3), MSD (3), GEI (2), CCK (2).

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 213 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 163 days; 4 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 86 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 62 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 20077cite it
  • K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 20154cite it
  • K851140Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 19854cite it
  • K132362Weck Efx Endo Fascial Closure SystemTeleflexmedical, Inc. · 20134cite it
  • K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK…Teleflexmedical, Inc. · 20163cite it
  • K920908Over the Needle Splitable Catheter Assembly Type 1Teleflexmedical, Inc. · 19923cite it

What has FDA decided for it lately?

  • K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024
  • K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
  • K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc. · 2019
  • K182847Hudson RCI Voldyne Volumetric ExerciserTeleflexmedical, Inc. · 2019
  • K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc. · 2019
  • K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent CatheterTeleflexmedical, Inc. · 2019
  • K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
  • K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 20181 Class I recall

All 64 as Teleflexmedical, Inc. →

What has been recalled?

51 recalls linked to its devices; the latest:

  • K111117NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX…Apr 10, 2026Class I
  • K111117Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-IApr 10, 2026Class I
  • K111117Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP…Apr 10, 2026Class I
  • K142153HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP.…Aug 4, 2023Class I
  • K162242HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port…Dec 13, 2019Class I
  • K162242HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer…Dec 13, 2019Class I