510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860352Substantially Equivalent

Spacelabs Airway Adapter Set Series, No. 369014

Spacelabs, Inc., Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860352 is the FDA 510(k) clearance record for SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014, a class I device, cleared for Spacelabs, Inc. on under FDA product code BZA (Connector, Airway (Extension)). FDA records list 46 510(k) clearances for Spacelabs, Inc., from to . As of , FDA records show no recalls naming K860352.

Clearance record

Decision date
Received
(48 days to decision)
Product code
BZA Connector, Airway (Extension)
Regulation
21 CFR 868.5810
Device class
Class I
Review panel
Anesthesiology
Applicant
Spacelabs, Inc. 20550 Prairie St., Chatsworth CA
Third party review
No

Clearances, product code BZA

Trailing 12 months

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

FDA records show no clearances under product code BZA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZA, 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