510(k) Report

510(k) · Cleared

Recalled · 2009

Resolution Hemostasis Clipping Device

K040148510(k) TraditionalCleared Apr 22, 200490-day reviewClass II21 CFR 878.4300Recalls 2

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

Boston Scientific Corp · MCH Clip, Hemostatic

Cleared on Apr 22, 2004 as substantially equivalent to K013066 (Olympus America, Inc., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1997. 48 later devices descend from it. It has been recalled 2 times.

Decided
Apr 22, 2004
Review
90 days
Class
Class II
Product code
MCH
Recalls
2
Predicates
3

Its longest line of descent runs back 3 generations to K963160 (1997). 48 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2010: 2 descendants cleared2022: 8 descendants cleared2024: 7 descendants cleared2014: 1 descendant cleared2015: 2 descendants cleared2018: 5 descendants cleared2019: 2 descendants cleared2017: 1 descendant cleared2020: 4 descendants cleared2023: 2 descendants cleared2025: 6 descendants cleared2021: 2 descendants cleared2026: 4 descendants clearedK963160 · HX-5/6-1 Endoscopic Clipping Device · Olympus America, Inc. · 1997K990687 · HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips · Olympus Optical, Co. · 1999K013066 · HX-5/6-1 Endoscopic Clipping Device · Olympus America, Inc. · 2001 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 15 descendants4 generations forward: 14 descendants5 generations forward: 8 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K013066 · HX-5/6-1 Endoscopic Clipping Device · Olympus America, Inc. · 2001 · recalledK990687 · HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips · Olympus Optical, Co. · 1999K963160 · HX-5/6-1 Endoscopic Clipping Device · Olympus America, Inc. · 19970+5
  1. Root · 3 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
  2. 2 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
  3. 1 generation backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
  4. This deviceK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004
  5. Descendant · cites it directly · 39 of its ownK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
  6. Descendant · 2 generations on · 23 of its ownK142973 Resolution ClipBoston Scientific Corporation · 2014
  7. Descendant · 3 generations on · 19 of its ownK151802 Resolution ClipBoston Scientific Corporation · 2015
  8. Descendant · 2 generations on · 15 of its ownK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
  9. Descendant · 3 generations on · 13 of its ownK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2010: 22012: 22014: 12015: 22017: 12018: 52019: 22020: 42021: 22022: 82023: 22024: 72025: 62026: 4
2010high 8 (2022) · low 0 (2011)2026

Most influential descendants

Showing 5 of 48 · See all
  • K122660Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612Boston Scientific Corporation · 2012 · cites it directly39descendants
  • K142973Resolution ClipBoston Scientific Corporation · 2014 · 2 generations on23descendants
  • K151802Resolution ClipBoston Scientific Corporation · 2015 · 3 generations on19descendants
  • K152001Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015 · 2 generations on15descendants
  • K161463SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017 · 3 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K963160HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc.1997—
−2K990687HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co.1999—
−1K013066HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc.20011
0 (this device)K040148Resolution Hemostasis Clipping DeviceBoston Scientific Corp2004—
+1K122660Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611…Boston Scientific Corporation2012—
+2K142973Resolution ClipBoston Scientific Corporation2014—
+3K151802Resolution ClipBoston Scientific Corporation2015—
+2K152001Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd.2015—
+3K161463SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201220
201410
201520
201710
201850
201920
202040
202120
202280
202320
202470
202560
202640
FIG. 1 — Lineage of K040148, 1997–2026Source: 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 MCH? 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
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
*K013066HX-5/6-1 Endoscopic Clipping Device
Summary page 4
…n Senior Regulatory Affairs Specialist Resolution™ Hemostasis Clipping Device Endoscopic Clipping Device Class II, per 21 CFR Part 876.4400 Olympus Clip Fixing Device (K013066, K990687, K963160) The Resolution™ Hemostasis Clipping Device is a single-use pre-loaded mechanical clip and delivery system use…
Olympus America, Inc.20011
*K990687HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips
Summary page 4
…Regulatory Affairs Specialist Resolution™ Hemostasis Clipping Device Endoscopic Clipping Device Class II, per 21 CFR Part 876.4400 Olympus Clip Fixing Device (K013066, K990687, K963160) The Resolution™ Hemostasis Clipping Device is a single-use pre-loaded mechanical clip and delivery system used for end…
Olympus Optical, Co.1999—
*K963160HX-5/6-1 Endoscopic Clipping Device
Summary page 4
…y Affairs Specialist Resolution™ Hemostasis Clipping Device Endoscopic Clipping Device Class II, per 21 CFR Part 876.4400 Olympus Clip Fixing Device (K013066, K990687, K963160) The Resolution™ Hemostasis Clipping Device is a single-use pre-loaded mechanical clip and delivery system used for endoscopic c…
Olympus America, Inc.1997—

Also cleared against K013066: 1 other device →

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K122660Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612Boston Scientific Corporation201239
K101428Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG20106
K102764Resolution II ClipBoston Scientific Corporation20100

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 17, 2009Not classifiedZ-1896-2009Process controlThe clip may not deploy or, if deployed, the clip may not release from the tissue.
Jun 17, 2009Not classifiedZ-1895-2009Process controlThe clip may not deploy or, if deployed, the clip may not release from the tissue.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K122660 (Boston Scientific Corporation, 2012) has gone furthest, with 39 descendants of its own.
  • 1 other device also cites its predicate K013066.

How does its category compare?

All MCH devices

MCH Clip, Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCH

FDA has decided no MCH device since 2007.

Median 510(k) review, days · MCH

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

Recalls per year · MCH

No recall names MCH since 2007.

Adverse event reports per year · MCH

1in 2023

2008: 12009: 12014: 472015: 412017: 12018: 922019: 772020: 532021: 272022: 1252023: 1
2007high 125 (2022) · low 0 (2007)2025

MAUDE reports naming product code MCH, 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—01
20090—01
20100—00
20110—00
20120—00
20130—00
20140—047
20150—041
20160—00
20170—01
20180—092
20190—077
20200—053
20210—027
20220—0125
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

- endoscopic marking

- hemostasis for mucosal/submucosal defects <1cm, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, diverticula in the colon

- anchoring to affix jejunal feeding tubes to the wall of the small bowel

- as a supplemental closure method of luminal perforations <20mm that can be treated conservatively.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K013066

1 other device cites the same predicate.

  • K123601Single Use Repositionable ClipOlympus Medical Systems Corp. · 20134 recalls

More from Boston Scientific Corp

4,014 FDA decisions under this applicant name. See the company

  • P900056/S229ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P900056/S226ROTAPRO™ Rotational Atherectomy SystemsBoston Scientific Corp · 2026
  • P900056/S228ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P150031/S100Vercise DBS SystemsBoston Scientific Corp · 2026
  • N970003/S311ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2…Boston Scientific Corp · 2026

Recent decisions in MCH

The MCH category page

  • K972745Titanium Hemostatic ClipEisner USA, Inc. · 1997
  • K896998Atrauclip (Tantalum Hemostatic Clip)S.P.K. Technology, Inc. · 1990

https://510kreport.com/device/K040148 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040148: Resolution Hemostasis Clipping Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040148

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