510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962158Substantially Equivalent

Pico Models 30, 50, 70

Radiometer America, Inc, Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962158 is the FDA 510(k) clearance record for PICO MODELS 30, 50, 70, a class II device, cleared for Radiometer America, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 50 510(k) clearances for Radiometer America, Inc., from to . As of , FDA records show one recall naming K962158.

Clearance record

Decision date
Received
(147 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Radiometer America, Inc. 810 Sharon Dr., Westlake OH
510(k) summary
Summary
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260