# Tyco Healthcare

- Location (FDA's records): Mansfield, MA
- FDA decisions: 14 (2001–2007): 14 510(k) clearances
- Product codes: FRO (3), KOD (2), FMI (2), EZL (2), NGT (1), KSR (1), FMF (1), FOZ (1), JOW (1)
- Predicates its devices cite: 17 (1 its own); citations of its devices by later devices: 17 (1 its own)
- Recalls linked to its devices: 120 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kendall: 3 (https://510kreport.com/company/kendall)
- Sherwood Medical Co.: 2 (https://510kreport.com/company/sherwood-medical)
- Kendall Healthcare Products Co. Div.Of Tyco Health: 2 (https://510kreport.com/company/kendall-healthcare-products-co-div-of-tyco-health)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Concord/Portex: 1 (https://510kreport.com/company/concord-portex)
- Maersk Medical, Ltd.: 1 (https://510kreport.com/company/maersk-medical)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Sol-Millennium Medical, Inc.: 2 (https://510kreport.com/company/sol-millennium-medical)
- Cardinal Health200, LLC: 1 (https://510kreport.com/company/cardinal-health200)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Tyco Healthcare/Kendall: 1 (https://510kreport.com/company/tyco-healthcare-kendall)
- Winner Medical Co., Ltd.: 1 (https://510kreport.com/company/winner-medical)
- Hygia Health Services, Inc.: 1 (https://510kreport.com/company/hygia-health-services)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe (2006), cited by 4
- K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve (2004), cited by 3
- K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe (2004), cited by 2
- K012736: Monoject Safety Needle (2001), cited by 2
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 (2007), cited by 2
- K013556: Monoject Prefill Heparin Lock Flush Syringe (2001), cited by 2

## Recent decisions
- K071049: Dover 100% Silicone Foley Catheter with Temperature Sensor (Oct 16, 2007)
- K070685: Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 (Sep 14, 2007)
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 (Sep 12, 2007)
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe (Aug 3, 2006)
- K042709: Dover Silver Temperature Sensing Foley Catheter (Jan 18, 2005)
- K040897: Dover Rob-Nel Catheter (Jul 20, 2004)
- K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve (Jul 15, 2004)
- K041243: Dover Red Rubber Robinson Catheter (Jul 7, 2004)

Source page: https://510kreport.com/company/tyco-healthcare