Ivwatch, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ivwatch, LLC” (first 2015, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Since 2017 the median was 98 days, against 117 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 |
|---|---|---|
| 2015 | 1 | 171 |
| 2016 | 2 | 82 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 303 |
| 2021 | 0 | — |
| 2022 | 1 | 30 |
| 2023 | 0 | — |
| 2024 | 1 | 98 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ivwatch, LLC took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | 5 | 5 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Ivwatch, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233881 | ivWatch® Model 400 | PMS | 2024-03-15 | 98 |
| K222212 | ivWatch Model 400 | PMS | 2022-08-24 | 30 |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | PMS | 2020-07-02 | 303 |
| K162478 | ivWatch | PMS | 2016-12-22 | 107 |
| K153605 | ivWatch Model 400 | PMS | 2016-02-11 | 56 |
| K142374 | ivWatch Model 400 | MRZ | 2015-02-13 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Ivwatch, 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.
Device clinical trials
An industry sponsor named Ivwatch, LLC is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04065373: ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues (Completed, started 2019-04-25)
- NCT04064229: ivWatch Sensor: Device Validation for Infiltrated Tissues (Completed, started 2019-04-03)
- NCT02553421: Optical Detection of Intravenous Infiltration:A Pilot Study (Completed, started 2015-08)
- NCT02123745: ivWatch Model 400: Device Validation for Infiltrated Tissues (Completed, started 2014-02)
- NCT02120443: ivWatch Model 400: Device Validation for Non-Infiltrated Tissues (Completed, started 2014-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ivwatch, LLC (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ivwatch, LLC?
FDA lists 6 510(k) clearances under the applicant name “Ivwatch, LLC” (first 2015, latest 2024), across 2 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 Ivwatch, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivwatch, LLC is 102 days. Since 2017: 98 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ivwatch, LLC?
The most frequent FDA product codes under this applicant name are PMS (Peripheral Intravenous (Piv) Infiltration Monitor, 5); MRZ (Accessories, Pump, Infusion, 1).
Next steps
- See all 6 Ivwatch, LLC clearances with predicates and recalls
- Run predicate analysis for product code PMS, Ivwatch, 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, 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.