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
K992857Substantially Equivalent

Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070

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

K992857 is the FDA 510(k) clearance record for LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070, a class II device, cleared for Rocky Mountain Research, Inc. on under FDA product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass). FDA records list 5 510(k) clearances for Rocky Mountain Research, Inc., from to . As of , FDA records show no recalls naming K992857.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation
21 CFR 870.4340
Device class
Class II
Review panel
Cardiovascular
Applicant
Rocky Mountain Research, Inc. 825 N. 300 W., Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code DTW

Trailing 12 months

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

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