510(k) Report

FDA applicant

Tyco Healthcare

Mansfield, MA14 decisions2001–2007120 recalls

FDA records 14 decisions for Tyco Healthcare (Mansfield, MA) from 2001 to 2007: 14 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KOD (Catheter, Urological). Its devices cite 17 predicates, 1 of them its own earlier devices. 120 recalls are linked to its devices, 4 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

5in 2021

2007: 22008: 82010: 62013: 92021: 5, 4 Class I
2007high 9 (2013) · low 0 (2009)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FRODressing, Wound, Drug3decisions
  • KODCatheter, Urological2decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • EZLCatheter, Retention Type, Balloon2decisions
  • NGTSaline, Vascular Access Flush1decision
  • KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components1decision

Also: FMF (1), FOZ (1), JOW (1).

Whose devices does it build on?

Its devices cite 17 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K061492Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare · 20064cite it
  • K040649Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare · 20043cite it
  • K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare · 20042cite it
  • K012736Monoject Safety NeedleTyco Healthcare · 20012cite it
  • K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare · 20072cite it
  • K013556Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 20012cite it

What has FDA decided for it lately?

  • K071049Dover 100% Silicone Foley Catheter with Temperature SensorTyco Healthcare · 2007
  • K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
  • K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
  • K061492Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare · 2006
  • K042709Dover Silver Temperature Sensing Foley CatheterTyco Healthcare · 2005
  • K040897Dover Rob-Nel CatheterTyco Healthcare · 2004
  • K040649Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare · 2004
  • K041243Dover Red Rubber Robinson CatheterTyco Healthcare · 2004

All 14 as Tyco Healthcare →

What has been recalled?

120 recalls linked to its devices; the latest:

  • K032438Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside…Aug 19, 2021Class I
  • K032438Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code…Aug 4, 2021Class I
  • K032438Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125…Aug 4, 2021Class I
  • K032438Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123…Aug 4, 2021Class I
  • K012736Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A…Feb 9, 2021Class II
  • K032438Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID…Aug 16, 2013Class II

Other applicant names beginning “Tyco”

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

Tyco Healthcare Group LP 6Tyco Healthcare/Kendall 4Tyco Healthcare Nancy 2Tyco Intl. (Us), Inc. 1Tyco Electronics Corporation 1Tyco Healthcare Deutschaland GmbH 1