510(k) Report

FDA applicant

Ace Medical Us, LLC

Powell, OH2 decisions2006–200962 recalls

FDA records 2 decisions for Ace Medical Us, LLC (Powell, OH) from 2006 to 2009: 2 510(k) clearances. All are in product code MEB (Pump, Infusion, Elastomeric). Its devices cite 7 predicates, 1 of them its own earlier devices. 62 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 Ace Medical Us, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

16in 2018

2009: 462018: 16
2007high 46 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ace Medical Us, 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, Elastomeric2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060258AutofuserAce Medical Us, LLC · 20061cites it

What has FDA decided for it lately?

  • K090300Modification to AutofuserAce Medical Us, LLC · 200916 recalls
  • K060258AutofuserAce Medical Us, LLC · 200646 recalls

All 2 as Ace Medical Us, LLC →

What has been recalled?

62 recalls linked to its devices; the latest:

  • K090300AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser…Oct 2, 2018Class II
  • K090300AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain…Oct 2, 2018Class II
  • K090300AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser…Oct 2, 2018Class II
  • K090300AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser…Oct 2, 2018Class II
  • K090300AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser…Oct 2, 2018Class II
  • K090300AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain…Oct 2, 2018Class II