# K221700: AutoPulse NXT Resuscitation System

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation, Inc.
- Decided: Mar 9, 2023 after 269 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K851139 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112998: Autopulse Resuscitation System Model 1000, Zoll Circulation (2012) Summary page 4.

## Recalls of this device
- Mar 4, 2025 · Class I · Z-1533-2025: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

## Indications for use
The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient. The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Source page: https://510kreport.com/device/K221700
Methodology: https://510kreport.com/methodology