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
K990378Substantially Equivalent

Statview System

Data Critical Corp., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990378 is the FDA 510(k) clearance record for STATVIEW SYSTEM, a class II device, cleared for Data Critical Corp. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 11 510(k) clearances for Data Critical Corp., from to . As of , FDA records show no recalls naming K990378.

Clearance record

Decision date
Received
(224 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Data Critical Corp. 19820 N. Creek Pkwy., Bothell WA
510(k) summary
Summary
Third party review
No

Clearances, product code MSX

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