510(k) Report

510(k) · Cleared

Cleared

Disposable Endoscopic Cannula

K140213510(k) TraditionalCleared Mar 25, 2015421-day reviewClass II21 CFR 884.5070

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

Dongguan Microview Medical Technology Co., Ltd. · HGH Cannula, Suction, Uterine

Cleared on Mar 25, 2015 as substantially equivalent to K093508 (Womancare Global, 2010) after a 421-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.

Decided
Mar 25, 2015
Review
421 days
Class
Class II
Product code
HGH
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K813282 (1981). 1 later device descends from it, 1 citing it directly.

  1. Root · 3 generations backK813282 Synevac Vacuum Curettage SystemsSynemed, Inc. · 1981
  2. 2 generations backK030935 Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003 · Recalled
  3. 1 generation backK093508 Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global · 2010
  4. This deviceK140213 Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd. · 2015
  5. Descendant · cites it directly · 0 of its ownK172151 Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K172151Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K813282Synevac Vacuum Curettage SystemsSynemed, Inc.1981—
−2K030935Berkeley V-10 Vacuum Curettage SystemAcmi Corporation20031
−1K093508Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global2010—
0 (this device)K140213Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd.2015—
+1K172151Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K140213, 1981–2018Source: 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), 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 HGH? 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? (1)

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
*K093508Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)
Summary page 6
…21CFR 884.5070 Classification and Class II Product code HGH 510(k) number K093508 5. Indications for Use The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the uterine cavity…
Womancare Global2010—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K172151Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd.20180

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 34 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K172151 (Chongquin Jinshan Science & Technology (Group) Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HGH devices

HGH Cannula, Suction, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HGH

1in 2018

2010: 12015: 12017: 12018: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGH

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

Recalls per year · HGH

No recall names HGH since 2007.

Adverse event reports per year · HGH

1in 2024

2010: 32012: 12013: 12014: 12024: 1
2007high 3 (2010) · low 0 (2007)2025

MAUDE reports naming product code HGH, 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—00
20080—00
20090—00
20101—03
20110—00
20120—01
20130—01
20140—01
20151—00
20160—00
20171—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K140213: Disposable Endoscopic Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140213

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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