510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915427Substantially Equivalent

Ors-1000

Mnlase, Inc., Reston VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915427 is the FDA 510(k) clearance record for ORS-1000, a class I device, cleared for Mnlase, Inc. on under FDA product code JRM (Freezer). FDA records list 22 510(k) clearances for Mnlase, Inc., from to . As of , FDA records show no recalls naming K915427.

Clearance record

Decision date
Received
(36 days to decision)
Product code
JRM Freezer
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Mnlase, Inc. 11250 Roger Bacon Dr. #10, Reston VA
510(k) summary
Statement
Third party review
No

Clearances, product code JRM

Trailing 12 months

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

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