510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896857Substantially Equivalent

Solcotrans Orthopaedic Drainage/reinfusion System

Solco Basle, Inc., Hingham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896857 is the FDA 510(k) clearance record for SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM, a class II device, cleared for Solco Basle, Inc. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 10 510(k) clearances for Solco Basle, Inc., from to . As of , FDA records show no recalls naming K896857.

Clearance record

Decision date
Received
(121 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Solco Basle, Inc. 72 Sharp St., Hingham MA
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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