510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950415Substantially Equivalent

Fluoroscan Neonatal

Isolab, Inc., Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950415 is the FDA 510(k) clearance record for FLUOROSCAN NEONATAL, a class I device, cleared for Isolab, Inc. on under FDA product code KHO (Fluorometer, For Clinical Use). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show no recalls naming K950415.

Clearance record

Decision date
Received
(217 days to decision)
Product code
KHO Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Isolab, Inc. Drawer 4350, Akron OH
510(k) summary
Statement
Third party review
No

Clearances, product code KHO

Trailing 12 months

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

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