Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Richard-Allan Medical Ind., Inc. · Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
209 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931879 | REFLEX HTR | Richard-Allan Medical Ind., Inc. | 1994-03-24 | 344 | 0 |
| K924200 | REFLEX(R) ESC | Richard-Allan Medical Ind., Inc. | 1994-02-22 | 551 | 0 |
| K926297 | REFLEX ESI | Richard-Allan Medical Ind., Inc. | 1993-10-15 | 305 | 0 |
| K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | Richard-Allan Medical Ind., Inc. | 1993-04-20 | 209 | 0 |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | Richard-Allan Medical Ind., Inc. | 1990-05-03 | 85 | 0 |
| K896262 | TITANIUM LIGATING CLIPS | Richard-Allan Medical Ind., Inc. | 1990-01-02 | 64 | 0 |
| K890314 | PROTECTOR (SURGICAL INSTRUMENT) | Richard-Allan Medical Ind., Inc. | 1989-02-27 | 35 | 0 |
| K873309 | REFLEX(TM) CA-T CLIP APPLIER | Richard-Allan Medical Ind., Inc. | 1987-11-27 | 101 | 0 |
| K862404 | REFLEX(TM) CLIP APPLIER | Richard-Allan Medical Ind., Inc. | 1986-07-23 | 28 | 0 |
| K862223 | MICRO THIN* PARAFFIN | Richard-Allan Medical Ind., Inc. | 1986-06-17 | 6 | 0 |
| K861890 | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | Richard-Allan Medical Ind., Inc. | 1986-06-03 | 18 | 0 |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | 1983-08-12 | 18 | 0 |
| K830867 | REFLEX ONE STAPLE EXTRACTOR | Richard-Allan Medical Ind., Inc. | 1983-04-12 | 25 | 0 |
| K830625 | CYTO-STAIN | Richard-Allan Medical Ind., Inc. | 1983-03-24 | 23 | 0 |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | 1983-03-24 | 23 | 0 |
| K822145 | COMPLETE | Richard-Allan Medical Ind., Inc. | 1982-10-22 | 93 | 0 |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | 1981-10-29 | 20 | 0 |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | 1981-10-29 | 20 | 0 |
| K811800 | BLUING REAGENT | Richard-Allan Medical Ind., Inc. | 1981-08-12 | 49 | 0 |
| K811793 | FIX-RIGHT 90ML & 180 ML PREFILLED CONT | Richard-Allan Medical Ind., Inc. | 1981-07-31 | 37 | 0 |
| K811799 | CLEAR-MOUNT | Richard-Allan Medical Ind., Inc. | 1981-07-31 | 37 | 0 |
| K811794 | 37% FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811795 | 10% NEUTRAL BUFFERED FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811796 | FORMAL ALCOHOL | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811797 | EOSIN-Y | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811801 | CAL-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K811802 | HEMATOXYLIN | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K790660 | SURGICAL RULER | Richard-Allan Medical Ind., Inc. | 1979-04-12 | 10 | 0 |
| K790661 | PROTECTOR II | Richard-Allan Medical Ind., Inc. | 1979-04-12 | 10 | 0 |
| K771611 | PROTECTOR | Richard-Allan Medical Ind., Inc. | 1977-09-06 | 15 | 0 |
| K761323 | SURGICAL MARKING PEN | Richard-Allan Medical Ind., Inc. | 1977-01-12 | 16 | 0 |
| K761322 | SURGICAL BLADES | Richard-Allan Medical Ind., Inc. | 1977-01-06 | 10 | 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