Tz Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Tz Medical, Inc.” (first 1992, latest 2026), plus 1 PMA decision, across 10 product codes in 3 review panels. Median 510(k) review time under this name: 203 days. Since 2017 the median was 90 days, against 156 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 90 |
| 2018 | 1 | 54 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 262 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tz Medical, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| DXC | Clamp, Vascular | 3 | 3 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 2 | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 1 | 0 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
- Cardiovascular (14)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Tz Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | DXC | 2026-05-22 | 262 |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | DXC | 2018-01-10 | 54 |
| K163322 | TZ SKULL PIN Adult | HBL | 2017-02-23 | 90 |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | DSI | 2011-06-13 | 285 |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | DSA | 2006-12-15 | 106 |
| K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | QSY | 2004-05-11 | 102 |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | DRF | 2003-04-18 | 350 |
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | DXH | 2000-12-21 | 209 |
| K993205 | BOOKER BOX, MODEL PAD 5010 | LDD | 2000-07-20 | 300 |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | DRO | 1999-09-15 | 366 |
5 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200005 | PMA | TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | 2024-01-09 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2016-07-07.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tz Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Tz Medical, Inc.” (first 1992, latest 2026), plus 1 PMA decision, across 10 product codes in 3 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 Tz Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tz Medical, Inc. is 203 days. Since 2017: 90 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tz Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); DXC (Clamp, Vascular, 3); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 2).
Next steps
- See all 15 Tz Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Tz Medical, 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.