510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K122355Substantially Equivalent

Vanishpoint Blood Collection Set

Retractable Technologies, Inc., Little Elm TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122355 is the FDA 510(k) clearance record for VANISHPOINT BLOOD COLLECTION SET, a class II device, cleared for Retractable Technologies, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 13 510(k) clearances for Retractable Technologies, Inc., from to . As of , FDA records show no recalls naming K122355.

Clearance record

Decision date
Received
(385 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
Retractable Technologies, Inc. 511 Lobo Ln., Little Elm TX
510(k) summary
Summary PDF
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