510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981845Substantially Equivalent

Hawk Anaesthesia Induction Unit

Medical Industrial Equipment, Exeter, Devon, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981845 is the FDA 510(k) clearance record for HAWK ANAESTHESIA INDUCTION UNIT, a class II device, cleared for Medical Industrial Equipment on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 2 510(k) clearances for Medical Industrial Equipment, from to . As of , FDA records show no recalls naming K981845.

Clearance record

Decision date
Received
(161 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Industrial Equipment Falcon Rd. Sowton Industrial, Exeter, Devon, GB
510(k) summary
Statement
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260