510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910982Substantially Equivalent

Innervision Irrigation Pump

M.D. Engineering, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910982 is the FDA 510(k) clearance record for INNERVISION IRRIGATION PUMP, a class II device, cleared for M.D. Engineering, Inc. on under FDA product code HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic). FDA records list 4 510(k) clearances for M.D. Engineering, Inc., from to . As of , FDA records show no recalls naming K910982.

Clearance record

Decision date
Received
(172 days to decision)
Product code
HEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
M.D. Engineering, Inc. 2536 Barrington Ct., Hayward CA
Third party review
No

Clearances, product code HEI

Trailing 12 months

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

FDA records show no clearances under product code HEI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEI, 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