510(k) Report

FDA applicant

Teleflex, Inc.

Durham, NC11 decisions1986–202522 recalls

FDA records 11 decisions for Teleflex, Inc. (Durham, NC) from 1986 to 2025: 11 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and CAZ (Anesthesia Conduction Kit). Its devices cite 14 predicates, 1 of them its own earlier devices. 22 recalls are linked to its devices, 4 Class I.

FDA’s records also spell it “Teleflex Incorporated”.

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 Teleflex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 22013: 12014: 32015: 12016: 12025: 1
2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2026

2013: 12014: 12015: 22018: 22019: 8, 2 Class I2020: 52026 (partial year): 3, 2 Class I
2007high 8 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Teleflex, 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?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)3decisions
  • CAZAnesthesia Conduction Kit3decisions
  • DYBIntroducer, Catheter3decisions
  • BSOCatheter, Conduction, Anesthetic1decision
  • BTRTube, Tracheal (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 14 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 20124cite it
  • K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 20121cites it
  • K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 20141cites it
  • K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 20151cites it

What has FDA decided for it lately?

  • K241451Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes…Teleflex Incorporated · 2025
  • K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2016
  • K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 20151 Class I recall
  • K141940Conchasmart ColumnTeleflex, Inc. · 2014
  • K140556Conchasmart Breathing CircuitTeleflex, Inc. · 2014
  • K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 20142 Class I recalls
  • K123974Percutaneous Introducer KitTeleflex, Inc. · 2013
  • K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 20121 Class I recall

All 10 as Teleflex, Inc. →The one decision as Teleflex Incorporated →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K140110Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…Apr 21, 2026Class I
  • K001587Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY…Apr 21, 2026Class I
  • K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER…Mar 11, 2026Class II
  • K140110Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes…May 8, 2020Class II
  • K140110FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRHJan 15, 2020Class II
  • K103658FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1Jan 15, 2020Class II

Other applicant names beginning “Teleflex”

FDA records each applicant name separately; these may or may not be the same firm.

Teleflex Medical 46Teleflex Medical Sdn. Bhd. 3Teleflex Medical Group 1