510(k) Report

FDA applicant

Aircast, Inc.

Summit, NJ11 decisions1978–20031 recall

FDA records 11 decisions for Aircast, Inc. (Summit, NJ) from 1978 to 2003: 11 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and IQI (Orthosis, Limb Brace). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Aircast, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aircast, Inc. since 2007.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • JOWSleeve, Limb, Compressible7decisions
  • IQIOrthosis, Limb Brace2decisions
  • ILOPack, Hot Or Cold, Water Circulating1decision
  • ITQJoint, Knee, External Brace1decision

Who builds on its devices?

Later devices cite its devices 10 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.

  • K992454Venaflow System, Model 30AAircast, Inc. · 20004cite it
  • K023800Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017Aircast, Inc. · 20033cite it
  • K932900Aircast Venaflow SystemAircast, Inc. · 19932cite it
  • K024019Arterialflow System, Model 32AAircast, Inc. · 20031cites it

What has FDA decided for it lately?

  • K024019Arterialflow System, Model 32AAircast, Inc. · 2003
  • K023800Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017Aircast, Inc. · 2003
  • K992454Venaflow System, Model 30AAircast, Inc. · 2000
  • K964238Aircast Vena Flow Sterile Disposable CuffsAircast, Inc. · 19971 recall
  • K961676Aircast Venaflow System (Modification)Aircast, Inc. · 1997
  • K933977Aircast Edemaflow SystemAircast, Inc. · 1993
  • K932900Aircast Venaflow SystemAircast, Inc. · 1993
  • K925677Autochill Accessory KitAircast, Inc. · 1993

All 11 as Aircast, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K964238Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date…Jan 17, 2019Class II