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
K944120Substantially Equivalent

Fi02 Sensing Module

Core-M, Inc., Allston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944120 is the FDA 510(k) clearance record for FI02 SENSING MODULE, a class II device, cleared for Core-M, L.P. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 4 510(k) clearances for Core-M, L.P., from to . As of , FDA records show no recalls naming K944120.

Clearance record

Decision date
Received
(260 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Core-M, L.P. 129 Braintree St., Allston MA
510(k) summary
Statement
Third party review
No

Clearances, product code CCL

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