Innerspace, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Innerspace, Inc.” (first 2001, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 216 days. 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 | 196 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 7 | 7 |
| HCA | Catheter, Ventricular | 1 | 1 |
Review panels
- Neurology (8)
Most recent Innerspace, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113088 | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | GWM | 2012-05-02 | 196 |
| K083378 | SYNERGY | GWM | 2009-09-29 | 319 |
| K072379 | MPS OXIPORT AND MPS OXIPORT PLUS | GWM | 2008-04-29 | 249 |
| K041838 | MPS (OR MPS-T) | GWM | 2005-03-01 | 237 |
| K013705 | ACT III VENTRICULAR CATHETER | GWM | 2002-09-09 | 305 |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | HCA | 2002-03-08 | 183 |
| K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | GWM | 2001-06-28 | 136 |
| K003905 | ACTI-ICP MONITORING SYSTEM | GWM | 2001-06-15 | 178 |
Recalls
openFDA lists no recalls under a recalling firm named Innerspace, Inc..
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.
- Innerspace Medical, Inc. (1 510(k)s)
- Innerspace Neuro Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innerspace, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Innerspace, Inc.” (first 2001, latest 2012), 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 Innerspace, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innerspace, Inc. is 216 days.
Which FDA product codes appear under Innerspace, Inc.?
The most frequent FDA product codes under this applicant name are GWM (Device, Monitoring, Intracranial Pressure, 7); HCA (Catheter, Ventricular, 1).
Next steps
- See all 8 Innerspace, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWM, Innerspace, 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.