510(k) Report

FDA applicant

Symbios Medical Products, LLC

Indianapolis, IN3 decisions2005–20071 recall

FDA records 3 decisions for Symbios Medical Products, LLC (Indianapolis, IN) from 2005 to 2007: 3 510(k) clearances. All are in product code MEB (Pump, Infusion, Elastomeric). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 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 Symbios Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Symbios Medical Products, LLC 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?

  • MEBPump, Infusion, Elastomeric3decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051474Symbios Disposable Infusion Pump KitSymbios Medical Products, LLC · 20051cites it

What has FDA decided for it lately?

  • K072921Disposable Infusion Pump Kit, GO Pump Rapid Recovery SystemSymbios Medical Products, LLC · 20071 Class I recall
  • K071735Modification to Disposable Infusion Pump KitSymbios Medical Products, LLC · 2007
  • K051474Symbios Disposable Infusion Pump KitSymbios Medical Products, LLC · 2005

All 3 as Symbios Medical Products, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072921GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual…Feb 25, 2013Class I