Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pentax Precision Instrument Corp. · Predicate Candidate Screening
67 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
266 days90th percentile
67clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041397 | EG-3830UT | Pentax Precision Instrument Corp. | 2004-06-09 | 14 | 1 |
| K041395 | EG-3630UR | Pentax Precision Instrument Corp. | 2004-06-09 | 14 | 0 |
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2004-06-09 | 14 | 1 |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2003-08-08 | 59 | 0 |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2003-02-11 | 125 | 0 |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Pentax Precision Instrument Corp. | 2002-10-16 | 8 | 3 |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-09-12 | 143 | 0 |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-09-06 | 137 | 0 |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-02-04 | 91 | 0 |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2001-04-17 | 35 | 0 |
| K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR | Pentax Precision Instrument Corp. | 1997-09-04 | 279 | 0 |
| K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE | Pentax Precision Instrument Corp. | 1997-02-10 | 266 | 2 |
| K963056 | ED-3410, VIDEO DUODENOSCOPE | Pentax Precision Instrument Corp. | 1996-10-10 | 65 | 1 |
| K962897 | EG-3400, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-10-04 | 71 | 1 |
| K962460 | EG-3800T, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-09-16 | 83 | 1 |
| K961568 | ED-344OT | Pentax Precision Instrument Corp. | 1996-07-09 | 77 | 0 |
| K961564 | EG-2940, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-07-09 | 77 | 2 |
| K961567 | ES-3840, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-06-24 | 62 | 0 |
| K961570 | KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENO | Pentax Precision Instrument Corp. | 1996-06-24 | 62 | 1 |
| K961563 | EC-384OTL, VIDEO COLONSCOPE | Pentax Precision Instrument Corp. | 1996-06-19 | 57 | 0 |
| K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | 352 | 1 |
| K951574 | EC-3800L, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | 352 | 3 |
| K951579 | EC-3800TL, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | 352 | 1 |
| K953876 | PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) | Pentax Precision Instrument Corp. | 1995-11-24 | 109 | 0 |
| K953286 | FCP-9P, FIBER CHOLEDOCHOSCOPE | Pentax Precision Instrument Corp. | 1995-11-03 | 113 | 1 |
| K951576 | FS-34P2, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-29 | 86 | 0 |
| K951575 | FC-38TLH, FIBER COLONOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | 84 | 0 |
| K951580 | FC-38LH, FIBER COLONOSCCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | 84 | 0 |
| K951573 | FS-38H, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | 84 | 0 |
| K951572 | FS-38X, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | 84 | 2 |
| K951578 | FC-38LX, FIBER COLONOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | 84 | 1 |
| K933683 | PENTAX FACE MASK | Pentax Precision Instrument Corp. | 1995-06-02 | 673 | 0 |
| K951197 | FE-24X, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | 75 | 0 |
| K951198 | FE-34TH, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | 75 | 0 |
| K951191 | FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | 75 | 1 |
| K951199 | FB-18X, FIBER BRONCHOSCOPE | Pentax Precision Instrument Corp. | 1995-04-10 | 25 | 2 |
| K951196 | FNL-10P, FIBER NASOPARHYNGOSCOPE | Pentax Precision Instrument Corp. | 1995-04-07 | 22 | 0 |
| K951195 | FI-10P | Pentax Precision Instrument Corp. | 1995-04-06 | 21 | 0 |
| K951194 | FI-10M | Pentax Precision Instrument Corp. | 1995-04-06 | 21 | 0 |
| K934918 | EPM-3300 VIDEO PROCESSOR | Pentax Precision Instrument Corp. | 1994-02-07 | 115 | 0 |
| K934920 | VB-1830/VB-1530, VIDEO BRONCHOSCOPE | Pentax Precision Instrument Corp. | 1994-01-26 | 103 | 0 |
| K921315 | PENTAX XENON LIGHT SOURCE | Pentax Precision Instrument Corp. | 1993-06-25 | 464 | 0 |
| K921707 | PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 | Pentax Precision Instrument Corp. | 1992-07-01 | 82 | 1 |
| K915274 | METAL HALIDE LIGHT SOURCE MODEL LM 250 | Pentax Precision Instrument Corp. | 1992-01-23 | 59 | 0 |
| K914106 | PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P | Pentax Precision Instrument Corp. | 1992-01-10 | 119 | 1 |
| K914008 | PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P | Pentax Precision Instrument Corp. | 1992-01-10 | 123 | 1 |
| K904573 | PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA | Pentax Precision Instrument Corp. | 1991-06-12 | 246 | 0 |
| K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 | Pentax Precision Instrument Corp. | 1985-07-09 | 186 | 3 |
| K833924 | TWO CHANNEL GASTROFIBERSCOPE FG-36T | Pentax Precision Instrument Corp. | 1984-02-04 | 82 | 0 |
| K832492 | BRONCHO FIBERSCOPE FB-19C | Pentax Precision Instrument Corp. | 1983-09-20 | 55 | 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