510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003305Substantially Equivalent

Pediatric Ingestascan

Adams Electronics, Inc., Enid OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003305 is the FDA 510(k) clearance record for PEDIATRIC INGESTASCAN, a class II device, cleared for Adams Electronics, Inc. on under FDA product code HPM (Locator, Metal, Electronic). FDA records list one 510(k) clearance for Adams Electronics, Inc. As of , FDA records show no recalls naming K003305.

Clearance record

Decision date
Received
(63 days to decision)
Product code
HPM Locator, Metal, Electronic
Regulation
21 CFR 886.4400
Device class
Class II
Review panel
Ophthalmic
Applicant
Adams Electronics, Inc. 110 A Sunset Plz., Enid OK
510(k) summary
Statement
Third party review
No

Clearances, product code HPM

Trailing 12 months

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

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