Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Penox Technologies, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
99 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864667 | PENOX HOSPITAL BED | Penox Technologies, Inc. | 1987-01-21 | 50 | 0 |
| K863978 | PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) | Penox Technologies, Inc. | 1986-12-15 | 62 | 0 |
| K862654 | MODIFIED PENOX LIFT CHAIR | Penox Technologies, Inc. | 1986-07-18 | 7 | 0 |
| K853775 | PENOX HIGH FLOW MANIFOLD | Penox Technologies, Inc. | 1985-11-29 | 80 | 0 |
| K852109 | PENOX PERFORMER WHEELCHAIR | Penox Technologies, Inc. | 1985-08-22 | 99 | 0 |
| K851218 | PENOX LIFT CHAIR | Penox Technologies, Inc. | 1985-06-21 | 87 | 0 |
| K851217 | PENOX DUAL FLOW MINIFOLD | Penox Technologies, Inc. | 1985-06-18 | 84 | 0 |
| K851219 | FILL HOSE SAFETY ADAPTER | Penox Technologies, Inc. | 1985-06-18 | 84 | 0 |
| K851216 | PENOX DUAL FEED MANIFOLD | Penox Technologies, Inc. | 1985-06-18 | 84 | 0 |
| K851215 | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | Penox Technologies, Inc. | 1985-06-18 | 84 | 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