Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Vision-Sciences, Inc. — Predicate Candidate Screening

33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

76 daysmedian FDA review time

248 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K102733	VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TEC	Vision-Sciences, Inc.	2011-05-18	238	0
K100125	VISION SCIENCES FLEXIBLE ENT SCOPE	Vision-Sciences, Inc.	2010-02-25	37	2
K091768	VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH S	Vision-Sciences, Inc.	2009-08-03	48	0
K072180	VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SY	Vision-Sciences, Inc.	2007-12-18	134	0
K071127	FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM	Vision-Sciences, Inc.	2007-11-16	207	0
K072088	FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO	Vision-Sciences, Inc.	2007-08-29	30	0
K072073	VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH E	Vision-Sciences, Inc.	2007-08-29	30	0
K071903	ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE	Vision-Sciences, Inc.	2007-08-02	23	0
K053560	MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE	Vision-Sciences, Inc.	2006-03-16	85	0
K050972	VISION-SCIENCES ENT-3000 SCOPE	Vision-Sciences, Inc.	2005-04-29	11	2
K040984	VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNG	Vision-Sciences, Inc.	2004-04-27	12	0
K040215	VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON E	Vision-Sciences, Inc.	2004-04-15	76	0
K031786	TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM	Vision-Sciences, Inc.	2003-08-05	56	0
K031790	SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING	Vision-Sciences, Inc.	2003-07-02	22	0
K024095	MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM	Vision-Sciences, Inc.	2003-01-09	28	0
K012543	VISION SCIENCES ENDOSHEATH SYSTEM	Vision-Sciences, Inc.	2002-07-15	342	0
K021344	B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM	Vision-Sciences, Inc.	2002-05-24	25	0
K990354	ENDOSHEATH	Vision-Sciences, Inc.	1999-03-31	54	0
K964326	VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOS	Vision-Sciences, Inc.	1997-01-03	65	0
K963795	VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21	Vision-Sciences, Inc.	1996-12-23	91	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
K950809	VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARY	Vision-Sciences, Inc.	1996-08-05	530	0
K961591	DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE	Vision-Sciences, Inc.	1996-07-02	69	0
K942265	FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH	Vision-Sciences, Inc.	1995-12-22	592	0
K943715	VISION SYSTEM UPPER G.I. EXDOSCOPE	Vision-Sciences, Inc.	1995-02-24	207	0
K943895	VISION SYSTEM COLONSCOPE	Vision-Sciences, Inc.	1995-02-03	178	0
K932843	FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH	Vision-Sciences, Inc.	1994-02-14	248	0
K933247	PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS	Vision-Sciences, Inc.	1993-11-22	143	0
K925421	ENDOSHEATH	Vision-Sciences, Inc.	1993-01-15	80	0
K921690	FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM	Vision-Sciences, Inc.	1992-10-28	203	0
K921244	DISPOSABLE PROTECTIVE SHEATH	Vision-Sciences, Inc.	1992-10-06	204	0
K863367	FORMALENS 2000	Vision-Sciences, Inc.	1986-09-26	23	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