510(k) Report

510(k) · Cleared

Recalled · 2008

Conmed Vcare Retractor/Elevator

K955446510(k) TraditionalCleared Jun 18, 1996202-day reviewClass II21 CFR 884.4530Recalls 3

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

Conmedcorp · LKF Cannula, Manipulator/Injector, Uterine

Cleared on Jun 18, 1996 after a 202-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it. It has been recalled 3 times.

Decided
Jun 18, 1996
Review
202 days
Class
Class II
Product code
LKF
Recalls
3
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955446 Conmed Vcare Retractor/ElevatorConmedcorp · 1996
  2. Descendant · cites it directly · 7 of its ownK071907 Vcare Retractor/ElevatorConmed Corporation · 2007 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK142716 VCAREConmed Corporation · 2015
  4. Descendant · 2 generations on · 1 of its ownK142164 Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014
  5. Descendant · 2 generations on · 1 of its ownK131781 Clearview TotalClinical Innovations, LLC · 2014 · Recalled
  6. Descendant · cites it directly · 1 of its ownK093556 Vcare DXConmed Corporation · 2010

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12014: 22015: 22017: 12018: 12022: 1
2007high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • K071907Vcare Retractor/ElevatorConmed Corporation · 2007 · cites it directly7descendants
  • K142716VCAREConmed Corporation · 2015 · 2 generations on1descendant
  • K142164Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014 · 2 generations on1descendant
  • K131781Clearview TotalClinical Innovations, LLC · 2014 · 2 generations on1descendant
  • K093556Vcare DXConmed Corporation · 2010 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955446Conmed Vcare Retractor/ElevatorConmedcorp1996—
+1K071907Vcare Retractor/ElevatorConmed Corporation20074
+2K142716VCAREConmed Corporation2015—
+2K142164Manipulator; Manipulator ProGynetech Pty., Ltd.2014—
+2K131781Clearview TotalClinical Innovations, LLC20141
+1K093556Vcare DXConmed Corporation2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201420
201520
201710
201810
202210
FIG. 1 — Lineage of K955446, 1996–2022Source: 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 LKF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LKF device

  1. #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K071907Vcare Retractor/ElevatorConmed Corporation20077
K093556Vcare DXConmed Corporation20101

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 8, 2008Not classifiedZ-0178-2009Process change controlThe firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Sep 8, 2008Not classifiedZ-0180-2009Process change controlThe firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Sep 8, 2008Not classifiedZ-0179-2009Process change controlThe firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K071907 (Conmed Corporation, 2007) has gone furthest, with 7 descendants of its own.

How does its category compare?

All LKF devices

LKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKF

2in 2025

2007: 32009: 22010: 62011: 32013: 32014: 32015: 52016: 12017: 12018: 42019: 12022: 42024: 32025: 2
2007high 6 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKF

136in 2024

2007: 141 days median2010: 178 days median2011: 187 days median2013: 266 days median2014: 169 days median2015: 140 days median2018: 267 days median2022: 79 days median2024: 136 days median
2007high 267 (2018) · low 79 (2022)2026

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

Recalls per year · LKF

3in 2022

2008: 22012: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LKF

95in 2025

2007: 362008: 592009: 532010: 462011: 982012: 1042013: 532014: 452015: 532016: 622017: 642018: 232019: 762020: 1192021: 1892022: 1002023: 882024: 1252025: 95
2007high 189 (2021) · low 23 (2018)2025

MAUDE reports naming product code LKF, 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
20073141036
20080—259
20092—053
20106178046
20113187098
20120—2104
20133266053
20143169045
20155140053
20161—062
20171—064
20184267023
20191—076
20200—0119
20210—0189
20224793100
20230—088
202431360125
20252—095
20260—0—

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The LKF category page

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https://510kreport.com/device/K955446 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955446: Conmed Vcare Retractor/Elevator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955446

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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