510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123822Substantially Equivalent

Klein Touch Pump and Disposable Tubing Set

HK Surgical Inc, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123822 is the FDA 510(k) clearance record for KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET, a class II device, cleared for Hk Surgical, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list 4 510(k) clearances for Hk Surgical, Inc., from to . As of , FDA records show no recalls naming K123822.

Clearance record

Decision date
Received
(289 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Hk Surgical, Inc. 1271 Puerta Del Sol, San Clemente CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRN

Trailing 12 months
2 clearances under product code FRN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260