Innovative Health, LLC: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Innovative Health, LLC” (first 2016, latest 2024), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 143 days. Since 2017 the median was 146 days, against 146 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 |
|---|---|---|
| 2016 | 11 | 133 |
| 2017 | 7 | 135 |
| 2018 | 5 | 122 |
| 2019 | 8 | 173 |
| 2020 | 5 | 199 |
| 2021 | 5 | 140 |
| 2022 | 3 | 241 |
| 2023 | 2 | 342 |
| 2024 | 2 | 358 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innovative Health, LLC took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 23 | 23 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 7 | 7 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 6 | 6 |
| PNE | Reprocessed Catheter Introducer | 4 | 4 |
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | 3 | 3 |
| QLZ | Septostomy Catheter, Reprocessed | 2 | 2 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 1 | 1 |
| NLI | Catheter, Angiography, Reprocessed | 1 | 1 |
| NMK | Trocar, Reprocessed | 1 | 1 |
Review panels
- Cardiovascular (48)
Most recent Innovative Health, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | NLI | 2024-07-01 | 448 |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | PNE | 2024-04-04 | 269 |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | PNE | 2023-08-07 | 175 |
| K213584 | Reprocessed NRG Transseptal Needle | QLZ | 2023-04-04 | 508 |
| K221854 | Reprocesses Umbilical Cable | NLH | 2022-08-06 | 40 |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | 2022-05-25 | 447 |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | PNE | 2022-03-10 | 241 |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | NLG | 2021-12-20 | 110 |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | NLG | 2021-11-18 | 170 |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | NLH | 2021-09-15 | 141 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innovative Health, LLC.
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.
- Innovative Medical Systems, Inc. (22 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Diagnostic Systems, Inc. (11 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Surgical Designs, Inc. (9 510(k)s)
- Innovative Bioceramix, Inc. (8 510(k)s)
- Innovative Surgical, Inc. (7 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Health, LLC?
FDA lists 48 510(k) clearances under the applicant name “Innovative Health, LLC” (first 2016, latest 2024), across 9 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innovative Health, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Health, LLC is 143 days. Since 2017: 146 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Innovative Health, LLC?
The most frequent FDA product codes under this applicant name are NLH (Catheter, Recording, Electrode, Reprocessed, 23); OWQ (Reprocessed Intravascular Ultrasound Catheter, 7); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 6).
Next steps
- See all 48 Innovative Health, LLC clearances with predicates and recalls
- Run predicate analysis for product code NLH, Innovative Health, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.