510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K042082Substantially Equivalent

Airstrip Ob

Mp4 Solutions, LP, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042082 is the FDA 510(k) clearance record for AIRSTRIP OB, a class II device, cleared for Mp4 Solutions, LP on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list one 510(k) clearance for Mp4 Solutions, LP. As of , FDA records show no recalls naming K042082.

Clearance record

Decision date
Received
(171 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mp4 Solutions, LP 11 Lynn Batts Ln., San Antonio TX
510(k) summary
Statement
Third party review
No

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