510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K902104Substantially Equivalent

Orion Watchguard

Orion Industries, Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902104 is the FDA 510(k) clearance record for ORION WATCHGUARD, a class II device, cleared for Orion Industries on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list one 510(k) clearance for Orion Industries. As of , FDA records show no recalls naming K902104.

Clearance record

Decision date
Received
(170 days to decision)
Product code
HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Regulation
21 CFR 884.2720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Orion Industries 12811 Kenwood Ln., Suite 203, Fort Myers FL
Third party review
No

Clearances, product code HFM

Trailing 12 months

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

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