510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904633Substantially Equivalent

Spiroloop, Modification

Pneumedics, Inc., Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904633 is the FDA 510(k) clearance record for SPIROLOOP, MODIFICATION, a class II device, cleared for Pneumedics, Inc. on under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). FDA records list 3 510(k) clearances for Pneumedics, Inc., from to . As of , FDA records show no recalls naming K904633.

Clearance record

Decision date
Received
(168 days to decision)
Product code
CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Regulation
21 CFR 868.1430
Device class
Class II
Review panel
Anesthesiology
Applicant
Pneumedics, Inc. 291 Pepe'S Fram Rd., Milford CT
Third party review
No

Clearances, product code CCJ

Trailing 12 months
1 clearance under product code CCJ 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 CCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260