Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jedmed Instrument Co. — Predicate Candidate Screening
92 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
164 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Jedmed Instrument Co. | 2014-02-21 | 234 | 0 |
| K021750 | LID CHAIN EYELID WEIGHTS | Jedmed Instrument Co. | 2003-01-27 | 244 | 0 |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | Jedmed Instrument Co. | 1995-11-13 | 68 | 0 |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | Jedmed Instrument Co. | 1995-09-15 | 394 | 0 |
| K950925 | JEDMED LARYNGEAL SCOPE | Jedmed Instrument Co. | 1995-08-11 | 163 | 0 |
| K953457 | JEDMED SPECTRUM ENT CABINET | Jedmed Instrument Co. | 1995-08-11 | 21 | 0 |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | 1995-06-28 | 127 | 0 |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | 1995-06-21 | 162 | 0 |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | Jedmed Instrument Co. | 1995-02-07 | 138 | 0 |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Jedmed Instrument Co. | 1994-09-23 | 37 | 0 |
| K941356 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | 1994-05-19 | 59 | 0 |
| K935247 | JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER | Jedmed Instrument Co. | 1994-02-18 | 109 | 0 |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Jedmed Instrument Co. | 1993-10-12 | 302 | 0 |
| K924025 | OTO-BRITE HANDLE | Jedmed Instrument Co. | 1992-11-06 | 87 | 0 |
| K920988 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | 1992-05-15 | 74 | 0 |
| K912885 | KAPS 90 DEGREE FIBEROPTIC ADAPTOR | Jedmed Instrument Co. | 1991-08-30 | 60 | 0 |
| K910243 | MOBILE TREATMENT CART | Jedmed Instrument Co. | 1991-04-17 | 85 | 0 |
| K910707 | OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS | Jedmed Instrument Co. | 1991-04-10 | 49 | 0 |
| K910271 | VACPAC PORTABLE ASPIRATION SYSTEM | Jedmed Instrument Co. | 1991-03-20 | 56 | 0 |
| K910357 | SOM 6V | Jedmed Instrument Co. | 1991-02-19 | 21 | 0 |
| K904802 | VIDEO OTOSCOPE | Jedmed Instrument Co. | 1991-01-22 | 90 | 0 |
| K902076 | J2 MICROSCOPE | Jedmed Instrument Co. | 1990-08-01 | 85 | 0 |
| K896263 | RHINOMANOMETER | Jedmed Instrument Co. | 1990-04-16 | 167 | 0 |
| K896961 | HALUX EXLITE MINOR SURGERY LIGHT | Jedmed Instrument Co. | 1990-02-22 | 69 | 0 |
| K900161 | A-SCAN ROLL-AROUND STAND | Jedmed Instrument Co. | 1990-02-16 | 35 | 0 |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | 1990-02-16 | 35 | 0 |
| K896273 | SYSTEMA ENT CABINET | Jedmed Instrument Co. | 1990-01-26 | 88 | 0 |
| K896298 | JEDMED S CHAIR | Jedmed Instrument Co. | 1990-01-26 | 88 | 0 |
| K896274 | TYMPANOSCOPE | Jedmed Instrument Co. | 1990-01-26 | 88 | 0 |
| K896297 | FLEXIBLE NASOPHARYNGOSCOPE | Jedmed Instrument Co. | 1990-01-26 | 88 | 0 |
| K900160 | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | Jedmed Instrument Co. | 1990-01-24 | 12 | 0 |
| K896384 | FIBEROPTIC LIGHT SOURCE, FOI-1A | Jedmed Instrument Co. | 1990-01-23 | 78 | 0 |
| K896962 | TINY HALOGEN EXAM LIGHT | Jedmed Instrument Co. | 1989-12-29 | 14 | 0 |
| K896275 | JEDMED J-II CHAIR | Jedmed Instrument Co. | 1989-12-18 | 49 | 0 |
| K884934 | JEDMED KP6 COLPOSCOPE | Jedmed Instrument Co. | 1989-02-23 | 87 | 0 |
| K884933 | ENDOSTROBOSCOPE IV | Jedmed Instrument Co. | 1989-02-15 | 79 | 0 |
| K881958 | JEDMED MAXIM ENT CABINET | Jedmed Instrument Co. | 1988-07-15 | 66 | 0 |
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1988-06-15 | 22 | 0 |
| K863985 | EVOPORT 100 | Jedmed Instrument Co. | 1987-01-29 | 107 | 0 |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | Jedmed Instrument Co. | 1986-12-29 | 33 | 0 |
| K863615 | ENTHERMO IRRIGATION UNIT | Jedmed Instrument Co. | 1986-12-16 | 91 | 0 |
| K862569 | HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) | Jedmed Instrument Co. | 1986-08-14 | 38 | 0 |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1986-07-30 | 16 | 0 |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jedmed Instrument Co. | 1986-06-13 | 9 | 0 |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jedmed Instrument Co. | 1986-06-09 | 11 | 0 |
| K861298 | FISCH DRILL IRRIGATOR | Jedmed Instrument Co. | 1986-04-23 | 16 | 0 |
| K855021 | LARYNGEAL MIRROR PRE-WARMER | Jedmed Instrument Co. | 1986-03-20 | 94 | 0 |
| K845039 | OPERAID DISPOS. IRRIGATING KNIFE | Jedmed Instrument Co. | 1985-03-05 | 67 | 0 |
| K841807 | OPERAID NUCLEUS | Jedmed Instrument Co. | 1984-11-21 | 204 | 0 |
| K841721 | OPERAID SURGICAL DRAIN | Jedmed Instrument Co. | 1984-11-21 | 210 | 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