510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K051145Substantially Equivalent

Critiview

Critisense, Ltd., Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051145 is the FDA 510(k) clearance record for CRITIVIEW, a class II device, cleared for Critisense , Ltd. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 2 510(k) clearances for Critisense , Ltd., from to . As of , FDA records show no recalls naming K051145.

Clearance record

Decision date
Received
(259 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Critisense , Ltd. 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260