510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961598Substantially Equivalent

Els Automatic Tubing Clamp System

Rocky Mountain Research, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961598 is the FDA 510(k) clearance record for ELS AUTOMATIC TUBING CLAMP SYSTEM, a class II device, cleared for Rocky Mountain Research, Inc. on under FDA product code KRL (Detector, Bubble, Cardiopulmonary Bypass). FDA records list 5 510(k) clearances for Rocky Mountain Research, Inc., from to . As of , FDA records show no recalls naming K961598.

Clearance record

Decision date
Received
(203 days to decision)
Product code
KRL Detector, Bubble, Cardiopulmonary Bypass
Regulation
21 CFR 870.4205
Device class
Class II
Review panel
Cardiovascular
Applicant
Rocky Mountain Research, Inc. 2715 E. 3300 S., Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code KRL

Trailing 12 months

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

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