Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rms Div. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
95 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963367 | RMS K-WIRE | Rms Div. | 1996-10-30 | 64 | 0 |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Rms Div. | 1995-12-29 | 95 | 0 |
| K944848 | THE VIVACARE T.P.S. PROBE | Rms Div. | 1994-12-14 | 75 | 0 |
| K944557 | DW250 #91 | Rms Div. | 1994-11-03 | 48 | 0 |
| K941625 | DW234 #29 | Rms Div. | 1994-06-22 | 79 | 0 |
| K902403 | ELITE R/F SPOT FILM DRIVE | Rms Div. | 1990-08-01 | 62 | 0 |
| K902146 | SFD-035 SPOT FILM DEVICE | Rms Div. | 1990-05-31 | 17 | 0 |
| K896665 | EXT-600 TABLE, RADIOGRAPHIC, ELEVATING | Rms Div. | 1990-01-22 | 56 | 0 |
| K896119 | RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE | Rms Div. | 1989-11-27 | 34 | 0 |
| K896324 | ELITE 1500 RADIOGRAPHIC TILTING TABLE | Rms Div. | 1989-11-21 | 20 | 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