510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000959Substantially Equivalent

Criterion 60 or Pm 60

Caradyne, Ltd., Mccordsville IN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K000959 is the FDA 510(k) clearance record for CRITERION 60 OR PM 60, a class II device, cleared for Caradyne, Ltd. on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 5 510(k) clearances for Caradyne, Ltd., from to . As of , FDA records show no recalls naming K000959.

Clearance record

Decision date
Received
(90 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
Caradyne, Ltd. 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary
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