510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K062119Substantially Equivalent

Hlr Model 601 Heart Lung Resuscitator and Heartsaver 100

Medical Products Mfg., LLC, North Attleboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062119 is the FDA 510(k) clearance record for HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100, a class II device, cleared for Medical Products Mfg., LLC on under FDA product code DRM (Compressor, Cardiac, External). FDA records list one 510(k) clearance for Medical Products Mfg., LLC. As of , FDA records show no recalls naming K062119.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Medical Products Mfg., LLC 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRM

Trailing 12 months

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

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