510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951050Substantially Equivalent

Speculum, ENT (S3)

Pedia Pals, Inc., Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951050 is the FDA 510(k) clearance record for SPECULUM, ENT (S3), a class I device, cleared for Pedia Pals, Inc. on under FDA product code ERA (Otoscope). FDA records list 7 510(k) clearances for Pedia Pals, Inc., from to . As of , FDA records show no recalls naming K951050.

Clearance record

Decision date
Received
(42 days to decision)
Product code
ERA Otoscope
Regulation
21 CFR 874.4770
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Pedia Pals, Inc. 3939 International Gateway, Columbus OH
510(k) summary
Statement
Third party review
No

Clearances, product code ERA

Trailing 12 months

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

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