Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innerspace, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
237 daysmedian FDA review time
319 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113088 | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD | Innerspace, Inc. | 2012-05-02 | 196 | 0 |
| K083378 | SYNERGY | Innerspace, Inc. | 2009-09-29 | 319 | 0 |
| K072379 | MPS OXIPORT AND MPS OXIPORT PLUS | Innerspace, Inc. | 2008-04-29 | 249 | 0 |
| K041838 | MPS (OR MPS-T) | Innerspace, Inc. | 2005-03-01 | 237 | 0 |
| K013705 | ACT III VENTRICULAR CATHETER | Innerspace, Inc. | 2002-09-09 | 305 | 0 |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | 2002-03-08 | 183 | 0 |
| K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | Innerspace, Inc. | 2001-06-28 | 136 | 0 |
| K003905 | ACTI-ICP MONITORING SYSTEM | Innerspace, Inc. | 2001-06-15 | 178 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda