510(k) · Cleared
ClearedHLR Model 601 Heart Lung Resuscitator and Heartsaver 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Products Mfg., LLC · DRM Compressor, Cardiac, External
Cleared on Sep 22, 2006 after a 59-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 22, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRM device
- #1 K221700 AutoPulse NXT Resuscitation Systemscore -7.5 · 6 generations · Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DRM
Too few DRM 510(k)s in any year since 2007 to give a median.
Recalls per year · DRM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRM
690in 2025
MAUDE reports naming product code DRM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 2 | — | 1 | 13 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 1 | 483 |
| 2013 | 0 | — | 0 | 1,268 |
| 2014 | 1 | — | 0 | 664 |
| 2015 | 0 | — | 0 | 674 |
| 2016 | 2 | — | 0 | 639 |
| 2017 | 0 | — | 0 | 679 |
| 2018 | 1 | — | 0 | 783 |
| 2019 | 0 | — | 0 | 706 |
| 2020 | 0 | — | 0 | 844 |
| 2021 | 1 | — | 0 | 755 |
| 2022 | 0 | — | 1 | 730 |
| 2023 | 1 | — | 0 | 765 |
| 2024 | 0 | — | 0 | 710 |
| 2025 | 0 | — | 0 | 690 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062119: HLR Model 601 Heart Lung Resuscitator and Heartsaver 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062119
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026