510(k) Report

FDA applicant

Quest Medical, Inc.

Allen, TX39 decisions1980–20246 recalls

FDA records 39 decisions for Quest Medical, Inc. (Allen, TX) from 1980 to 2024: 39 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and DWF (Catheter, Cannula And Tubing, Vascular…). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 213 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 11 of them its own earlier devices. 6 recalls are linked to its devices.

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

FDA decisions per year

1in 2024

2012: 22015: 12016: 12017: 12018: 22020: 22021: 12022: 22024: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2010: 12015: 12019: 12022: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular12decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass8decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass5decisions
  • FRNPump, Infusion2decisions
  • OKSLacrimal Stents And Intubation Sets2decisions
  • LDRController, Infusion, Intravascular, Electronic2decisions

Also: FPK (1), FOZ (1), MJJ (1), DTL (1), JCY (1), JKA (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 166 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 213 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 11 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.

  • K002689Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 20013cite it
  • K040385Multiport Manifold Set with Swabable Valves, Model 9900Quest Medical, Inc. · 20043cite it
  • K800825Extension Set Quest Code #3000Quest Medical, Inc. · 19802cite it
  • K953838Myocardial Protection SystemQuest Medical, Inc. · 19962cite it
  • K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 20181cites it
  • K941916Quest Coronary Sinus Perfusion Cannula -FRCCQuest Medical, Inc. · 19951cites it

What has FDA decided for it lately?

  • K241058Lyka® PORT Needle Free Access Device (4170Y)Quest Medical, Inc. · 2024
  • K213846Q2 Blood Administration SetsQuest Medical, Inc. · 2022
  • K213588Q2 IV Administration SetsQuest Medical, Inc. · 2022
  • K202672Precision Delivery Infusion SetQuest Medical, Inc. · 20211 recall
  • K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
  • K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
  • K182442MiniGuard Arterial Safety ValveQuest Medical, Inc. · 2018
  • K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 20181 recall

All 39 as Quest Medical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K151079Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic…Jul 14, 2023Class II
  • K202672Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with…Dec 23, 2022Class II
  • K173716Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7…Dec 17, 2019Class II
  • K953838Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger…Oct 28, 2015Class II
  • K041979Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software…Jul 29, 2010
  • K953838Quest Myocardial Protection System (MPS) Arrest/Additive CassettesMay 23, 2003

Other applicant names beginning “Quest”

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

Quest Intl., Inc. 25Quest Diagnostics, Inc. 8Quest International, Inc. 3Quest Dental USA Corp. 2Quest Medical Imaging 2Quest Diagnostics Nichols Institute 1Quest Technologies Corp. 1Quest Enabling Designs, Ltd. 1