# K972525: Thumper

- Pathway: 510(k) (Traditional)
- Applicant: Michigan Instruments, Inc.
- Decided: Oct 2, 1997 after 87 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851139 (1985). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851139: Thumper Cardiopulmonary Resuscitator 1005, Michigan Instruments, Inc. (1985) Summary page 1.
- (no number) Thumper® Model 1004: named in the summary without a submission number

## Most influential descendants
- K053403: LUCAS (2006), 7 descendants of its own
- K073079: Thumper, Model: 1008 (2008), 6 descendants of its own
- K062401: Modification to Lucas (2006), 6 descendants of its own
- K090422: LUCAS 2 (2009), 5 descendants of its own
- K161768: LUCAS 3 Chest Compression System (2016), 2 descendants of its own

## Recalls of this device
- Feb 13, 2018 · Class III · Z-1632-2018: A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿
- Sep 14, 2006 · Not classified · Z-0178-2007: Failure to initiate compressions when turned on.
- Aug 4, 2006 · Not classified · Z-0119-2007: Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures

## Indications for use
This device is used to perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Source page: https://510kreport.com/device/K972525
Methodology: https://510kreport.com/methodology