Rms Div.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Rms Div.” (first 1989, latest 1996), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 59 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 | 0 | — |
| 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 |
|---|---|---|---|
| IXL | Device, Spot-Film | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 2 | 2 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| EIX | Probe, Periodontic | 1 | 1 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Review panels
- Radiology (5)
- Dental (3)
- Anesthesiology (1)
- Orthopedic (1)
Most recent Rms Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963367 | RMS K-WIRE | HTY | 1996-10-30 | 64 |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | CCW | 1995-12-29 | 95 |
| K944848 | THE VIVACARE T.P.S. PROBE | EIX | 1994-12-14 | 75 |
| K944557 | DW250 #91 | EJT | 1994-11-03 | 48 |
| K941625 | DW234 #29 | EJS | 1994-06-22 | 79 |
| K902403 | ELITE R/F SPOT FILM DRIVE | IXL | 1990-08-01 | 62 |
| K902146 | SFD-035 SPOT FILM DEVICE | IXL | 1990-05-31 | 17 |
| K896665 | EXT-600 TABLE, RADIOGRAPHIC, ELEVATING | IZZ | 1990-01-22 | 56 |
| K896119 | RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE | IXR | 1989-11-27 | 34 |
| K896324 | ELITE 1500 RADIOGRAPHIC TILTING TABLE | IXR | 1989-11-21 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Rms Div..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rms Div.?
FDA lists 10 510(k) clearances under the applicant name “Rms Div.” (first 1989, latest 1996), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rms Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rms Div. is 59 days.
Which FDA product codes appear under Rms Div.?
The most frequent FDA product codes under this applicant name are IXL (Device, Spot-Film, 2); IXR (Table, Radiographic, Tilting, 2); CCW (Laryngoscope, Rigid, 1).
Next steps
- See all 10 Rms Div. clearances with predicates and recalls
- Run predicate analysis for product code IXL, Rms Div.'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.