510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891247Substantially Equivalent

Behind-the-Ear Hearing Aid Model 404 Pp-Pc

Siemens Hearing Instruments, Inc., Piscataway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891247 is the FDA 510(k) clearance record for BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC, a class II device, cleared for Siemens Hearing Instruments, Inc. on under FDA product code ESF (Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent). FDA records list 42 510(k) clearances for Siemens Hearing Instruments, Inc., from to . As of , FDA records show no recalls naming K891247.

Clearance record

Decision date
Received
(21 days to decision)
Product code
ESF Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Siemens Hearing Instruments, Inc. 10 Corporate Pl. S., Piscataway NJ
Third party review
No

Clearances, product code ESF

Trailing 12 months

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

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