510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875305Substantially Equivalent

Model Uca / Spec System Uca

Spec Systems, Inc., Kernersville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875305 is the FDA 510(k) clearance record for MODEL UCA / SPEC SYSTEM UCA, a class II device, cleared for Spec Systems, Inc. on under FDA product code FZH (Apparatus, Air Handling, Room). FDA records list 2 510(k) clearances for Spec Systems, Inc., from to . As of , FDA records show no recalls naming K875305.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FZH Apparatus, Air Handling, Room
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Spec Systems, Inc. P.O. Box 644, Kernersville NC
Third party review
No

Clearances, product code FZH

Trailing 12 months

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

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