510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893420Substantially Equivalent

Masterlab Pft and Masterlab Body Box

Quinton, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893420 is the FDA 510(k) clearance record for MASTERLAB PFT AND MASTERLAB BODY BOX, a class II device, cleared for Quinton, Inc. on under FDA product code CCM (Plethysmograph, Pressure). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K893420.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CCM Plethysmograph, Pressure
Regulation
21 CFR 868.1750
Device class
Class II
Review panel
Anesthesiology
Applicant
Quinton, Inc. 2121 Terry Ave., Seattle WA
Third party review
No

Clearances, product code CCM

Trailing 12 months

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

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