510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K951423Substantially Equivalent

Aspirator, Continuous & Programmable Intermittent

ZOLL Medical Corporation, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951423 is the FDA 510(k) clearance record for ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT, a class II device, cleared for Impact Instrumentation, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K951423.

Clearance record

Decision date
Received
(22 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Impact Instrumentation, Inc. 27 Fairfield Pl., West Caldwell NJ
510(k) summary
Statement
Third party review
No

Clearances, product code BTA

Trailing 12 months
7 clearances under product code BTA in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260