# Quest Medical, Inc.

- Location (FDA's records): Allen, TX
- FDA decisions: 39 (1980–2024): 39 510(k) clearances
- Product codes: FPA (12), DWF (8), DTR (5), FRN (2), OKS (2), LDR (2), FPK (1), FOZ (1), MJJ (1), DTL (1), JCY (1), JKA (1)
- 510(k) review time since 2016: median 166 days, against 213 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 29 (11 its own); citations of its devices by later devices: 21 (11 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shiley, Inc.: 3 (https://510kreport.com/company/shiley)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- 3M Health Care, Sarns: 2 (https://510kreport.com/company/3m-health-care-sarns)
- Chiron Vision Corp.: 1 (https://510kreport.com/company/chiron-vision)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- American Omni Medical, Inc.: 1 (https://510kreport.com/company/american-omni-medical)
- Ivac Medical Systems: 1 (https://510kreport.com/company/ivac-medical-systems)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)

## Firms that cite its devices most
- Mcgaw, Inc.: 1 (https://510kreport.com/company/mcgaw)
- Velano Vascular: 1 (https://510kreport.com/company/velano-vascular)
- Rx Devices, LLC: 1 (https://510kreport.com/company/rx-devices)
- France Chirurgae Instrumentation: 1 (https://510kreport.com/company/france-chirurgae-instrumentation)
- Intrasafe Medical, LLC: 1 (https://510kreport.com/company/intrasafe-medical)
- Medtronic Bio-Medicus, Inc.: 1 (https://510kreport.com/company/medtronic-bio-medicus)
- Halkey-Roberts Corp.: 1 (https://510kreport.com/company/halkey-roberts)
- Chase Medical, Inc.: 1 (https://510kreport.com/company/chase-medical)

## Its most-cited devices
- K002689: Swabsite Swabbable Valve, Model 245000 (2001), cited by 3
- K040385: Multiport Manifold Set with Swabable Valves, Model 9900 (2004), cited by 3
- K800825: Extension Set Quest Code #3000 (1980), cited by 2
- K953838: Myocardial Protection System (1996), cited by 2
- K173716: MPS2 Myocardial Protection System Console (2018), cited by 1
- K941916: Quest Coronary Sinus Perfusion Cannula -FRCC (1995), cited by 1

## Recent decisions
- K241058: Lyka® PORT Needle Free Access Device (4170Y) (Dec 18, 2024)
- K213846: Q2 Blood Administration Sets (Jun 5, 2022)
- K213588: Q2 IV Administration Sets (Jun 2, 2022)
- K202672: Precision Delivery Infusion Set (Jan 21, 2021)
- K201984: MPS 3 ND Myocardial Protection System (Nov 20, 2020)
- K200438: MPS 3 Myocardial Protection System (Jun 19, 2020)
- K182442: MiniGuard Arterial Safety Valve (Nov 6, 2018)
- K173716: MPS2 Myocardial Protection System Console (Oct 1, 2018)

Source page: https://510kreport.com/company/quest-medical