510(k) Report

FDA applicant

Ackard Laboratories

Cranford, NJ2 decisions1985–20012 recalls

FDA records 2 decisions for Ackard Laboratories (Cranford, NJ) from 1985 to 2001: 2 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and LKF (Cannula, Manipulator/Injector, Uterine). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Ackard Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ackard Laboratories since 2007.

Recalls per year

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ackard Laboratories 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?

  • FMFSyringe, Piston1decision
  • LKFCannula, Manipulator/Injector, Uterine1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 20013cite it

What has FDA decided for it lately?

  • K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 20012 recalls
  • K852990Pao ValueAckard Laboratories · 1985

All 2 as Ackard Laboratories →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K013972Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during…Mar 31, 2022Class II
  • K013972CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For…Mar 31, 2022Class II