Class Class II
AutoPulse NXT Resuscitation System (K221700)
Description
AutoPulse NXT Resuscitation System by Zoll Circulation, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221700
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeDRM
Regulation Number870.5200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221700
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. AutoPulse NXT Resuscitation System (K221700) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | Zoll Circulation | 2012 |
Trace the full predicate network for K221700
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.