510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Sapimed Disposable Sigmoidoscope

K070915510(k) TraditionalCleared Jul 6, 200795-day reviewClass II21 CFR 876.1500Recalls 1

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

Sapimed S.P.A. · KDM Sigmoidoscope, Rigid, Non-Electrical

Cleared on Jul 6, 2007 as substantially equivalent to K770291 (Welch Allyn, Inc., 1977) after a 95-day review. Its family tree reaches back 1 generation to 1977. 9 later devices descend from it. It has been recalled once.

Decided
Jul 6, 2007
Review
95 days
Class
Class II
Product code
KDM
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K770291 (1977). 9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2023: 1 descendant clearedK770291 · Sigmoidoscope, Disposable, Model #53125 · Welch Allyn, Inc. · 197719801990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant K770291 · Sigmoidoscope, Disposable, Model #53125 · Welch Allyn, Inc. · 19770+5
  1. Root · 1 generation backK770291 Sigmoidoscope, Disposable, Model #53125Welch Allyn, Inc. · 1977
  2. This deviceK070915 Sapimed Disposable SigmoidoscopeSapimed S.P.A. · 2007
  3. Descendant · cites it directly · 6 of its ownK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
  4. Descendant · 2 generations on · 4 of its ownK091490 Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009
  5. Descendant · 3 generations on · 3 of its ownK103647 THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011
  6. Descendant · cites it directly · 1 of its ownK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
  7. Descendant · 4 generations on · 1 of its ownK121135 THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 12012: 12013: 12014: 12017: 12023: 1
2008high 1 (2008) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K080132THD Disposable Anoscope/ProctoscopeThd Spa · 2008 · cites it directly6descendants
  • K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009 · 2 generations on4descendants
  • K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011 · 3 generations on3descendants
  • K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014 · cites it directly1descendant
  • K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770291Sigmoidoscope, Disposable, Model #53125Welch Allyn, Inc.1977—
0 (this device)K070915Sapimed Disposable SigmoidoscopeSapimed S.P.A.2007—
+1K080132THD Disposable Anoscope/ProctoscopeThd Spa2008—
+2K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa2009—
+3K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa2011—
+1K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.2014—
+4K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201110
201210
201310
201410
201710
202310
FIG. 1 — Lineage of K070915, 1977–2023Source: 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 KDM? 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
*K770291Sigmoidoscope, Disposable, Model #53125
Summary page 1
…Device: Company Product 510(k) Welch Allyn, Inc Disposable Sigmoidoscope Model#53125 K770291 Description: The Proctoscopy set consists of a multi-use plastic Grip (Ref. A.413 1) and a choice of 3 different single use Inse…
Welch Allyn, Inc.1977—

Also cleared against K770291: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K080132THD Disposable Anoscope/ProctoscopeThd Spa20086
K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.20141

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 23, 2021Class IIZ-1901-2021Process controlDue to issue with product sterility. Sterilization service provider had falsified records.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K080132 (Thd Spa, 2008) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K770291.

How does its category compare?

All KDM devices

KDM Sigmoidoscope, Rigid, Non-Electrical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KDM

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDM

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

Recalls per year · KDM

No recall names KDM since 2007.

Adverse event reports per year · KDM

No MAUDE report names KDM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K770291

2 other devices cite the same predicate.

  • K232262LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton…Surgease Innovations Limited · 2023
  • K123013Endoscopic IntroducerNovadaq Technologies, Inc. · 2013

More from Sapimed S.P.A.

3 FDA decisions under this applicant name. See the company

  • K070881Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
  • K070913Self-Light Disposable AnoscopeSapimed S.P.A. · 20071 recall

https://510kreport.com/device/K070915 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070915: Sapimed Disposable Sigmoidoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070915

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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