510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880680Substantially Equivalent

King Systems, Breathing Bag

King Systems Corporation., Noblesville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880680 is the FDA 510(k) clearance record for KING SYSTEMS, BREATHING BAG, a class I device, cleared for King Systems Corp. on under FDA product code BTC (Bag, Reservoir). FDA records list 18 510(k) clearances for King Systems Corp., from to . As of , FDA records show no recalls naming K880680.

Clearance record

Decision date
Received
(13 days to decision)
Product code
BTC Bag, Reservoir
Regulation
21 CFR 868.5320
Device class
Class I
Review panel
Anesthesiology
Applicant
King Systems Corp. 15011 Herriman Blvd., Noblesville IN
Third party review
No

Clearances, product code BTC

Trailing 12 months

FDA records hold no clearances under product code BTC in the trailing twelve months.

FDA records show no clearances under product code BTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260