510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820338Substantially Equivalent

Impact, Models 306/307

ZOLL Medical Corporation, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820338 is the FDA 510(k) clearance record for IMPACT, MODELS 306/307, 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 K820338.

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. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BTA

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