510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K942162Substantially Equivalent

Sigma 8000 and Sigma 8002

Sigma Intl., Medina NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942162 is the FDA 510(k) clearance record for SIGMA 8000 AND SIGMA 8002, a class II device, cleared for Sigma Intl. on under FDA product code FRN (Pump, Infusion). FDA records list 3 510(k) clearances for Sigma Intl., from to . As of , FDA records show no recalls naming K942162.

Clearance record

Decision date
Received
(169 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sigma Intl. 11020 W. Center St. Ext, Medina NY
510(k) summary
Summary
Third party review
No

Clearances, product code FRN

Trailing 12 months
2 clearances under product code FRN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260