Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rudolf Riester GmbH & Co. KG · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
450 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002955 | EMPIRE N BLOOD PRESSURE MANOMETERS | Rudolf Riester GmbH & Co. KG | 2000-12-21 | 90 | 0 |
| K002954 | RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS | Rudolf Riester GmbH & Co. KG | 2000-12-21 | 90 | 0 |
| K972378 | SANAPHON N | Rudolf Riester GmbH & Co. KG | 1997-09-24 | 90 | 0 |
| K972379 | PRECISA N | Rudolf Riester GmbH & Co. KG | 1997-09-24 | 90 | 0 |
| K972377 | RI-MEGA | Rudolf Riester GmbH & Co. KG | 1997-09-24 | 90 | 0 |
| K972301 | BIG BEN SQUARE, BIG BEN ROUND | Rudolf Riester GmbH & Co. KG | 1997-09-17 | 90 | 0 |
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION | Rudolf Riester GmbH & Co. KG | 1997-01-09 | 70 | 0 |
| K950914 | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 | Rudolf Riester GmbH & Co. KG | 1995-07-24 | 151 | 0 |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | 1995-05-12 | 78 | 0 |
| K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCAL | Rudolf Riester GmbH & Co. KG | 1995-05-08 | 179 | 0 |
| K945425 | MCINTOSH, MILLER, FOREGGER BABY | Rudolf Riester GmbH & Co. KG | 1995-03-20 | 136 | 0 |
| K946043 | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | 1995-03-08 | 86 | 0 |
| K945640 | RI-SCOPE S OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1995-01-17 | 62 | 0 |
| K945507 | H 5100, H 5200, H 5300 | Rudolf Riester GmbH & Co. KG | 1994-12-09 | 30 | 0 |
| K942777 | MINIMUS II; MINIMUS II COLOR; BABYPHON | Rudolf Riester GmbH & Co. KG | 1994-07-27 | 57 | 0 |
| K925295 | EXACTA-SPEZIAL | Rudolf Riester GmbH & Co. KG | 1994-03-25 | 520 | 0 |
| K925294 | PRECISA | Rudolf Riester GmbH & Co. KG | 1994-02-23 | 490 | 0 |
| K925297 | RI-MED | Rudolf Riester GmbH & Co. KG | 1994-01-14 | 450 | 0 |
| K925755 | DE LUXE | Rudolf Riester GmbH & Co. KG | 1993-12-03 | 385 | 0 |
| K925756 | UNI II | Rudolf Riester GmbH & Co. KG | 1993-10-18 | 339 | 0 |
| K932504 | RI-FORMER | Rudolf Riester GmbH & Co. KG | 1993-10-15 | 147 | 0 |
| K932506 | RI-SCOPE (S) | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 140 | 0 |
| K925753 | UNI III | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 329 | 0 |
| K932503 | RI-MINI | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 140 | 0 |
| K932505 | RI-STAR | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 140 | 0 |
| K925752 | STANDARD | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 329 | 0 |
| K925754 | ECONOM | Rudolf Riester GmbH & Co. KG | 1993-10-08 | 329 | 0 |
| K925757 | OPHTHALMOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 | 263 | 0 |
| K925758 | OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 | 263 | 0 |
| K925759 | UNI I | Rudolf Riester GmbH & Co. KG | 1993-07-26 | 255 | 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