510(k) Report

510(k) · Cleared

Cleared

Depalt Vaginal Specuim and Depalt Lighting System

K072762510(k) TraditionalCleared Jan 22, 2008116-day reviewClass II21 CFR 884.4530

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

Depalt, Inc. · HIB Speculum, Vaginal, Nonmetal

Cleared on Jan 22, 2008 as substantially equivalent to K070964 (Welch Allyn, Inc., 2007) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.

Decided
Jan 22, 2008
Review
116 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K020726 (2002). 4 ancestors in all, the oldest K941272 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1994: 1 other ancestor2014: 1 descendant clearedK020726 · Dukal Disposable Vaginal Speculum, Small, Medium, and Large · Dukal Corp. · 2002K052314 · Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large · Dynarex Corp. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant K052314 · Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large · Dynarex Corp. · 2005K020726 · Dukal Disposable Vaginal Speculum, Small, Medium, and Large · Dukal Corp. · 20020
  1. Root · 2 generations backK020726 Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp. · 2002
  2. 1 generation backK052314 Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium…Dynarex Corp. · 2005
  3. This deviceK072762 Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008
  4. Descendant · cites it directly · 0 of its ownK133857 Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K020726Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp.2002—
−1K052314Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-LargeDynarex Corp.2005—
0 (this device)K072762Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc.2008—
+1K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K072762, 2002–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in HIB? 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 HIB device

  1. #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K070964Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System
Summary page 1
…Vaginal, Nonmetal Predicate Device: Kleenspec Single Use Vaginal Speculum and 790 series Cordless Illumination System by Welch Allyn, Inc. K070964 (51 Ok number) Dynarex Vaginal Speculum by Dynarex Corporation K052314 (51 Ok nu…
Welch Allyn, Inc.2007—
*K052314Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large
Summary page 1
…Illumination System by Welch Allyn, Inc. K070964 (51 Ok number) Dynarex Vaginal Speculum by Dynarex Corporation K052314 (51 Ok number) Bionix Reddy Lite listed with FDA on 12/30/1996. Device Class 1…
Dynarex Corp.2005—
*—Bionix Reddy Lite
Named without a submission number
—

Also cleared against K070964: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc.20140

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K133857 (Proa Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K070964.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HIB

2in 2014

2007: 12008: 22009: 12010: 12011: 12012: 12013: 12014: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIB

Too few HIB 510(k)s in any year since 2007 to give a median.

Recalls per year · HIB

1in 2015

2015: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · HIB

3in 2025

2007: 12008: 22009: 12010: 102011: 152012: 152013: 92014: 82015: 52016: 22017: 52018: 32019: 42020: 42021: 42022: 22023: 32024: 22025: 3
2007high 15 (2011) · low 1 (2007)2025

MAUDE reports naming product code HIB, 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
20071—01
20082—02
20091—01
20101—010
20111—015
20121—015
20131—09
20142—08
20150—15
20160—02
20170—05
20180—03
20190—04
20200—04
20210—04
20220—02
20230—03
20240—02
20250—03
20261—1—

What is it indicated for?

Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.

Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.

Indications for use as stated in the FDA summary.

Also cleared against K070964

2 other devices cite the same predicate.

  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall
  • K110766Kolplux SystemKolplast CI Ltda · 2011

Recent decisions in HIB

The HIB category page

  • K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
  • K132668Iob Disposable SpeculumIob Medical, Inc. · 2014
  • K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall

https://510kreport.com/device/K072762 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072762: Depalt Vaginal Specuim and Depalt Lighting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072762

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026