510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873039Substantially Equivalent

Model 820 Top=trak

Sierra Laboratories, Inc., Carmel Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873039 is the FDA 510(k) clearance record for MODEL 820 TOP=TRAK, a class I device, cleared for Sierra Laboratories, Inc. on under FDA product code BYN (Chair, Posture, For Cardiac And Pulmonary Treatment). FDA records list 12 510(k) clearances for Sierra Laboratories, Inc., from to . As of , FDA records show no recalls naming K873039.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BYN Chair, Posture, For Cardiac And Pulmonary Treatment
Regulation
21 CFR 868.5365
Device class
Class I
Review panel
Anesthesiology
Applicant
Sierra Laboratories, Inc. Pilot Rd., Carmel Valley CA
Third party review
No

Clearances, product code BYN

Trailing 12 months

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

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