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
K974036Substantially Equivalent

Pathway Vaginal/rectal Perineometer Probe

The Prometheus Group, Duxbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974036 is the FDA 510(k) clearance record for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE, a class II device, cleared for The Prometheus Group on under FDA product code HIR (Perineometer). FDA records list 11 510(k) clearances for The Prometheus Group, from to . As of , FDA records show no recalls naming K974036.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
The Prometheus Group 2 Mallards Cove, Duxbury MA
510(k) summary
Statement
Third party review
No

Clearances, product code HIR

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