510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942158Substantially Equivalent

Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint Kits

Anholt Technologies Inc., Wyckoff NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942158 is the FDA 510(k) clearance record for AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS, a class I device, cleared for Wfr/Aquaplast Corp. on under FDA product code EPP (Splint, Nasal). FDA records list 8 510(k) clearances for Anholt Technologies Inc., from to . As of , FDA records show no recalls naming K942158.

Clearance record

Decision date
Received
(87 days to decision)
Product code
EPP Splint, Nasal
Regulation
21 CFR 874.5800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Wfr/Aquaplast Corp. P.O. Box 635, Wyckoff NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EPP

Trailing 12 months

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

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