ACE COLD BANDAGE— 510(k) K810402

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code IME

Device class

Class 1

Regulation

21 CFR 890.5700

Advisory panel

Physical Medicine

Date received

1981-02-18

Decision date

1981-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K923627 — COLD PACK1993-04-14
• K915876 — HOTPAD1993-02-12
• K921446 — HOT OR COLD PACK (THERMIPAQ)1992-07-13
• K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS1991-01-22
• K882413 — SUBOCCIPITAL ICE PILLOW1988-11-30

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →