510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820712Substantially Equivalent

Sepcor Unit Collection Monitor

Separation Science Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820712 is the FDA 510(k) clearance record for SEPCOR UNIT COLLECTION MONITOR, a class I device, cleared for Separation Science Corp. on under FDA product code KSQ (Device, Blood Mixing And Blood Weighing). FDA records list 2 510(k) clearances for Separation Science Corp., from to . As of , FDA records show no recalls naming K820712.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KSQ Device, Blood Mixing And Blood Weighing
Regulation
21 CFR 864.9195
Device class
Class I
Review panel
Hematology
Applicant
Separation Science Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KSQ

Trailing 12 months

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

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