510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090061Substantially Equivalent

Airstrip Ob

AirStrip Technologies, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K090061 is the FDA 510(k) clearance record for AIRSTRIP OB, a class II device, cleared for Airstrip Technologies, LP on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 15 510(k) clearances for Airstrip Technologies, LP, from to . As of , FDA records show no recalls naming K090061.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Airstrip Technologies, LP 3303 Oakwell Ct., Suite 200, San Antonio TX
510(k) summary
Statement
Third party review
Yes

Clearances, product code HGM

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