510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921978Substantially Equivalent

Breath Tracker(tm) Model 1800 Can-O-Gauge

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

K921978 is the FDA 510(k) clearance record for BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE, a class II device, cleared for Core-M, Inc. on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 4 510(k) clearances for Core-M, Inc., from to . As of , FDA records show no recalls naming K921978.

Clearance record

Decision date
Received
(203 days to decision)
Product code
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation
21 CFR 868.2600
Device class
Class II
Review panel
Anesthesiology
Applicant
Core-M, Inc. P.O. Box 1080, Allston MA
510(k) summary
Statement
Third party review
No

Clearances, product code CAP

Trailing 12 months

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

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