510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885316Substantially Equivalent

Disposable Intrauterine Pressure Kit Model 13972A

Hewlett-Packard Co., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885316 is the FDA 510(k) clearance record for DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A, a class II device, cleared for Hewlett-Packard Co. on under FDA product code KXO (Monitor, Pressure, Intrauterine). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K885316.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KXO Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hewlett-Packard Co. 3000 Minuteman Rd., Andover MA
Third party review
No

Clearances, product code KXO

Trailing 12 months

FDA records hold no clearances under product code KXO in the trailing twelve months.

FDA records show no clearances under product code KXO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260