AutoPulse NXT Resuscitation System— 510(k) K221700
Substantially EquivalentZoll Circulation, Inc.
FDA 510(k) clearance K221700 for AutoPulse NXT Resuscitation System, Substantially Equivalent on 2023-03-09. Applicant: Zoll Circulation, Inc.. Device class: 2.
Clearance details
- Applicant
- Zoll Circulation, Inc.
- Product code
- Code DRM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code DRM
view allMore clearances from Zoll Circulation, Inc.
view all- K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
- K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
Adverse events under product code DRM
product code DRM- Death
- 82
- Injury
- 126
- Malfunction
- 4,539
- Total
- 4,747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K221700
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221700.
Data sourced from openFDA. This site is unofficial and independent of the FDA.