510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861749Substantially Equivalent

3X Blue Panoramic Loupes 13.5 Working Distance

Keeler Instruments, Inc., Broomall PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861749 is the FDA 510(k) clearance record for 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE, a class I device, cleared for Keeler Instruments, Inc. on under FDA product code FSP (Loupe, Diagnostic/Surgical). FDA records list 60 510(k) clearances for Keeler Instruments, Inc., from to . As of , FDA records show no recalls naming K861749.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FSP Loupe, Diagnostic/Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Keeler Instruments, Inc. 456 Pkwy., Broomall PA
Third party review
No

Clearances, product code FSP

Trailing 12 months

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

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