Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FAM — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
248 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964131 | ENDOSCOPE | Akos Biomedical, Inc. | 1997-06-27 | 255 | 0 |
| K970382 | VS-100 VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1997-04-17 | 73 | 0 |
| K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOS | Vision-Sciences, Inc. | 1997-01-03 | 65 | 0 |
| K964100 | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VS | Vision-Sciences, Inc. | 1996-12-16 | 66 | 0 |
| K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBL | Vision-Sciences, Inc. | 1996-11-21 | 87 | 0 |
| K961567 | ES-3840, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-06-24 | 62 | 0 |
| K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | 352 | 1 |
| K950429 | VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1995-08-01 | 180 | 0 |
| K951576 | FS-34P2, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-29 | 86 | 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 |
| K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | Vision-Sciences, Inc. | 1994-02-14 | 248 | 0 |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | Vision-Sciences, Inc. | 1992-10-28 | 203 | 0 |
| K892000 | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE | Schott Fiber Optics, Inc. | 1989-04-25 | 28 | 0 |
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Harvard Laboratories | 1982-11-17 | 64 | 0 |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | American Optical Corp. | 1982-04-01 | 9 | 0 |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | American Optical Corp. | 1981-11-02 | 11 | 0 |
| K792341 | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 | Pentax Precision Instrument Corp. | 1979-12-10 | 21 | 0 |
| K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | Icl Scientific | 1979-12-06 | 20 | 0 |
| K790610 | SIGMOIDOSCOPE TIPLESS | Welch Allyn, Inc. | 1979-04-23 | 25 | 0 |
| K771815 | SIGMOSCOPE | Dynatech Cryomedical Co. | 1977-10-07 | 10 | 0 |
| K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 | Welch Allyn, Inc. | 1977-02-18 | 4 | 0 |
| K761180 | SIGMOIDOSCOPE/ DISPOSABLE | Smithkline Diagnostics, Inc. | 1977-01-05 | 34 | 0 |
| K760173 | BRIDGE, SHORT DEFLECTING | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 | 149 | 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