# K062119: HLR Model 601 Heart Lung Resuscitator and Heartsaver 100

- Pathway: 510(k) (Special)
- Applicant: Medical Products Mfg., LLC
- Decided: Sep 22, 2006 after 59 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator: named in the summary without a submission number

## Indications for use
The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation.

Source page: https://510kreport.com/device/K062119
Methodology: https://510kreport.com/methodology