Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O.R. Concepts, Inc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
286 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | O.R. Concepts, Inc. | 1994-08-17 | 149 | 0 |
| K935971 | FLOWGUN ELECTROCAUTERY PROBES | O.R. Concepts, Inc. | 1994-05-16 | 154 | 0 |
| K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE | O.R. Concepts, Inc. | 1994-05-16 | 154 | 0 |
| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | O.R. Concepts, Inc. | 1994-03-07 | 104 | 0 |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | O.R. Concepts, Inc. | 1993-10-15 | 308 | 0 |
| K922197 | INSUFFLATOR TUBING KIT | O.R. Concepts, Inc. | 1993-09-24 | 501 | 0 |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | O.R. Concepts, Inc. | 1993-09-24 | 499 | 0 |
| K932449 | DR. FOG | O.R. Concepts, Inc. | 1993-08-11 | 83 | 2 |
| K925147 | ORC 10.0MM SUCTION PROBE | O.R. Concepts, Inc. | 1993-06-25 | 255 | 0 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 | 231 | 0 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 | 286 | 0 |
| K923818 | O.R. CONCEPTS' IRRIGATING KITTNER | O.R. Concepts, Inc. | 1993-04-07 | 251 | 0 |
| K924022 | O.R. CONCEPTS SECONDARY CANNULA | O.R. Concepts, Inc. | 1993-03-18 | 219 | 0 |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | O.R. Concepts, Inc. | 1993-02-17 | 22 | 0 |
| K923416 | O.R. CONCEPTS' ELECTROSURGICAL PROBE | O.R. Concepts, Inc. | 1992-11-20 | 133 | 0 |
| K923199 | O.R. CONCEPTS ELECTROSURGICAL PROBES | O.R. Concepts, Inc. | 1992-11-20 | 143 | 0 |
| K924264 | O.R. CONCEPTS CABLE HARNESS | O.R. Concepts, Inc. | 1992-09-11 | 18 | 0 |
| K922405 | O.R.C. ADAPTER | O.R. Concepts, Inc. | 1992-08-14 | 85 | 0 |
| K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE | O.R. Concepts, Inc. | 1992-05-06 | 84 | 0 |
| K915057 | CANN-HOLD | O.R. Concepts, Inc. | 1992-03-19 | 132 | 0 |
| K915854 | ENDOSCOPIC TRANSLUMINATOR | O.R. Concepts, Inc. | 1992-03-18 | 82 | 0 |
| K915762 | POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1992-03-13 | 80 | 0 |
| K914960 | INSTRUMENT ORGANIZER | O.R. Concepts, Inc. | 1992-02-28 | 115 | 0 |
| K915214 | ARTHROSCOPY CAMERA DRAPE | O.R. Concepts, Inc. | 1992-01-09 | 52 | 0 |
| K914781 | SUCTION/IRRIGATION KITTNER | O.R. Concepts, Inc. | 1991-12-09 | 47 | 0 |
| K914782 | SUCTION/IRRIGATION PROBE | O.R. Concepts, Inc. | 1991-12-09 | 47 | 0 |
| K914377 | TROCAR | O.R. Concepts, Inc. | 1991-10-30 | 29 | 0 |
| K913500 | CHERRY SPONGE | O.R. Concepts, Inc. | 1991-09-25 | 49 | 1 |
| K893212 | THERMALAP | O.R. Concepts, Inc. | 1989-06-01 | 35 | 0 |
| K863182 | EYE BARRIER | O.R. Concepts, Inc. | 1986-09-03 | 15 | 0 |
| K860066 | REFLECTIVE BLANKET | O.R. Concepts, Inc. | 1986-02-19 | 44 | 0 |
| K860065 | SLUSH PAN COVER | O.R. Concepts, Inc. | 1986-02-07 | 32 | 0 |
| K860067 | MICROSCOPE COLUMN DRAPE | O.R. Concepts, Inc. | 1986-01-27 | 21 | 0 |
| K860068 | FOOT PEDAL COVER | O.R. Concepts, Inc. | 1986-01-27 | 21 | 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