510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991972Substantially Equivalent

Infant Flow System

Sensor Medics Corp., Yorba Linda CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K991972 is the FDA 510(k) clearance record for INFANT FLOW SYSTEM, a class II device, cleared for Sensor Medics Corp. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 26 510(k) clearances for Sensor Medics Corp., from to . As of , FDA records show no recalls naming K991972.

Clearance record

Decision date
Received
(63 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Sensor Medics Corp. 22705 Savi Ranch Pkwy., Yorba Linda CA
510(k) summary
Statement
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260