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
K893218Substantially Equivalent

Ap900/prp Module and Accessories, Modification

Electromedics, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893218 is the FDA 510(k) clearance record for AP900/PRP MODULE AND ACCESSORIES, MODIFICATION, a class II device, cleared for Electromedics, Inc. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 42 510(k) clearances for Electromedics, Inc., from to . As of , FDA records show no recalls naming K893218.

Clearance record

Decision date
Received
(411 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Electromedics, Inc. P.O. Box 3315, Englewood CO
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