510(k) Report

510(k) · Cleared

Recalled · 2006

Savary-Gilliard Dilator

K851955510(k) TraditionalCleared Jul 25, 198583-day reviewClass II21 CFR 876.5365Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · KNQ Dilator, Esophageal

Cleared on Jul 25, 1985 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Jul 25, 1985
Review
83 days
Class
Class II
Product code
KNQ
Recalls
1
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK851955 Savary-Gilliard DilatorWilson-Cook Medical, Inc. · 1985
  2. Descendant · cites it directly · 2 of its ownK031147 Optical DVS (Dual Vector Shearing) Esophageal DilatorEthicon Endo-Surgery, Inc. · 2004
  3. Descendant · 2 generations on · 0 of its ownK093236 Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc. · 2009
  4. Descendant · cites it directly · 0 of its ownK082995 Smart DilatorSafestitch Medical · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K031147Optical DVS (Dual Vector Shearing) Esophageal DilatorEthicon Endo-Surgery, Inc. · 2004 · cites it directly2descendants
  • K093236Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc. · 2009 · 2 generations on0descendants
  • K082995Smart DilatorSafestitch Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851955Savary-Gilliard DilatorWilson-Cook Medical, Inc.1985—
+1K031147Optical DVS (Dual Vector Shearing) Esophageal DilatorEthicon Endo-Surgery, Inc.2004—
+2K093236Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc.2009—
+1K082995Smart DilatorSafestitch Medical2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200920
FIG. 1 — Lineage of K851955, 1985–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031147Optical DVS (Dual Vector Shearing) Esophageal DilatorEthicon Endo-Surgery, Inc.20042
K082995Smart DilatorSafestitch Medical20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 5, 2006Not classifiedZ-0441-06OtherThe dilator size does not match the label on the product and product packaging.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K031147 (Ethicon Endo-Surgery, Inc., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KNQ devices

KNQ Dilator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNQ

1in 2012

2009: 32012: 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNQ

121in 2009

2009: 121 days median
2007high 121 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNQ

14in 2007

2007: 142026 (partial year): 4
2007high 14 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNQ

282in 2025

2007: 222008: 1282009: 3912010: 1762011: 2512012: 2512013: 2282014: 1642015: 2042016: 1542017: 2312018: 3962019: 3882020: 3642021: 3512022: 2742023: 3192024: 2682025: 282
2007high 396 (2018) · low 22 (2007)2025

MAUDE reports naming product code KNQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—1422
20080—0128
200931210391
20100—0176
20110—0251
20121—0251
20130—0228
20140—0164
20150—0204
20160—0154
20170—0231
20180—0396
20190—0388
20200—0364
20210—0351
20220—0274
20230—0319
20240—0268
20250—0282
20260—4—

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in KNQ

The KNQ category page

  • K122924Cre Fixed Wire Ballon Dilation CatheterBoston Scientific Corp · 2012
  • K093236Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc. · 2009
  • K090183Hercules 3 Stage Wire Guided Dilation BalloonCook Endoscopy · 2009
  • K082995Smart DilatorSafestitch Medical · 2009
  • K061937Cook Endoscopy Esophageal Dilation BalloonCook Endoscopy · 2006

https://510kreport.com/device/K851955 · printed Nov 5, 2026

Cite this page

510(k) Report. “K851955: Savary-Gilliard Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851955

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026