Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reimers Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
324 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102831 | RSI 4200 | Reimers Systems, Inc. | 2011-08-19 | 324 | 0 |
| K962869 | GSP1 - GAS SELECTION PANEL | Reimers Systems, Inc. | 1996-10-23 | 92 | 0 |
| K962871 | ODS1 - HOOD DRIVER | Reimers Systems, Inc. | 1996-10-23 | 92 | 0 |
| K954387 | T CLASS HYPERBARIC FACILITIES | Reimers Systems, Inc. | 1995-12-15 | 118 | 0 |
| K951125 | LIFEFORCE CLINICAL HYPERBARIC FACILITY | Reimers Systems, Inc. | 1995-06-02 | 81 | 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