510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K854654Substantially Equivalent for Some Indications

Sm Part Servo Sec. Duplex Dop 7-5/5 9814-219-50007

Philips North America LLC, Santa Ana CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K854654 is the FDA 510(k) clearance record for SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007, a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K854654.

Clearance record

Decision date
Received
(638 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems, Inc. 2722 S. Fairview St., Santa Ana CA
Third party review
No

Clearances, product code IYO

Trailing 12 months
9 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20261