Zoll Circulation, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Zoll Circulation, Inc.” (first 2006, latest 2025), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 170 days, against 193 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 160 |
| 2013 | 0 | — |
| 2014 | 1 | 154 |
| 2015 | 1 | 291 |
| 2016 | 1 | 139 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 1 | 149 |
| 2023 | 3 | 191 |
| 2024 | 0 | — |
| 2025 | 1 | 198 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zoll Circulation, Inc. took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NCX | System, Hypothermia, Intravenous, Cooling | 7 | 7 |
| DRM | Compressor, Cardiac, External | 4 | 4 |
| NZE | Hyperthermia Monitor | 2 | 2 |
| MWG | System, Oxygen, Aqueous | 1 | 0 |
Review panels
- Cardiovascular (7)
- Neurology (7)
Most recent Zoll Circulation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | NZE | 2025-10-15 | 198 |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | NZE | 2023-11-03 | 191 |
| K221700 | AutoPulse NXT Resuscitation System | DRM | 2023-03-09 | 269 |
| 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 | NCX | 2023-01-13 | 30 |
| 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 | NCX | 2022-06-02 | 149 |
| 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 | NCX | 2021-12-20 | 90 |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | NCX | 2016-03-24 | 139 |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | NCX | 2015-10-30 | 291 |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | NCX | 2014-10-03 | 154 |
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | DRM | 2012-03-15 | 160 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170027 | PMA | TherOx Downstream System | 2019-04-02 |
Recalls
34 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2025-03-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- ZOLL Medical Corporation (63 510(k)s)
- Zoll Medical Corporation, World Wide Headquarters (21 510(k)s)
- Zoll Manufacturing Corporation (3 510(k)s)
- Zoll Respicardia, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zoll Circulation, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Zoll Circulation, Inc.” (first 2006, latest 2025), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zoll Circulation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zoll Circulation, Inc. is 154 days. Since 2017: 170 days, versus 193 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zoll Circulation, Inc.?
The most frequent FDA product codes under this applicant name are NCX (System, Hypothermia, Intravenous, Cooling, 7); DRM (Compressor, Cardiac, External, 4); NZE (Hyperthermia Monitor, 2).
Next steps
- See all 13 Zoll Circulation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NCX, Zoll Circulation, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.