510(k) Report

FDA applicant

Summit Medical Products, Inc.

Salt Lake City, UT4 decisions2011–20175 recalls

FDA records 4 decisions for Summit Medical Products, Inc. (Salt Lake City, UT) from 2011 to 2017: 4 510(k) clearances. Most are in product codes BSO (Catheter, Conduction, Anesthetic) and MEA (Pump, Infusion, Pca). Its devices cite 3 predicates, 0 of them its own earlier devices. 5 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 Summit Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 32017: 1
2011high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

5in 2023

2023: 5
2011high 5 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Summit Medical Products, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Summit Medical Products, 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?

  • BSOCatheter, Conduction, Anesthetic2decisions
  • MEAPump, Infusion, Pca1decision
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K102460Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 20112cite it

What has FDA decided for it lately?

  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 20175 recalls
  • K113043Direct Antibiotic Infusion KitSummit Medical Products, Inc. · 2011
  • K110814Ambit TunnelerSummit Medical Products, Inc. · 2011
  • K102460Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 2011

All 4 as Summit Medical Products, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K162165ambIT Cassette Filter Male Luer, Product Code: 220266Apr 24, 2023Class II
  • K162165SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568Apr 24, 2023Class II
  • K162165AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509Apr 24, 2023Class II
  • K162165SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537Apr 24, 2023Class II
  • K162165AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507Apr 24, 2023Class II

Other applicant names beginning “Summit”

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

Summit Medical, Inc. 14Summit World Trade Corp. 10Summit Industries, Inc. 8Summit Doppler Systems, Inc. 7Summit Nuclear 6Summit Technology, Inc. 5Summit Glove, Inc. 5Summit Optics, Inc. 2Summit Spine 2Summit Medventures 2Summit Durable Medical Equipment, Inc. 1Summit TO Sea 1