510(k) Report

510(k) · Cleared

Cleared

Retriever 10

K921649510(k) TraditionalCleared Mar 11, 1993339-day reviewClass II21 CFR 870.1200

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

Target Therapeutics · DQO Catheter, Intravascular, Diagnostic

Cleared on Mar 11, 1993 after a 339-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 of the 42 devices in its family, counting itself, have a Class I recall. 41 later devices descend from it.

Decided
Mar 11, 1993
Review
339 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

41 later devices descend from it, 1 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2021: 1 descendant cleared2002: 1 descendant cleared2014: 3 descendants cleared2010: 2 descendants cleared, 1 with a Class I recall12003: 2 descendants cleared2004: 2 descendants cleared, 1 with a Class I recall12009: 2 descendants cleared2008: 1 descendant cleared2005: 1 descendant cleared2017: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared, 1 with a Class I recall12022: 3 descendants cleared2018: 3 descendants cleared2016: 3 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2024: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK921649 Retriever 10Target Therapeutics · 1993
  2. Descendant · cites it directly · 40 of its ownK970668 The Amplantz Goose Neck MicrosnareMicrovena Corp. · 1998
  3. Descendant · 2 generations on · 32 of its ownK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
  4. Descendant · 3 generations on · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
  5. Descendant · 4 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
  6. Descendant · 2 generations on · 11 of its ownK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12003: 22004: 22005: 12008: 12009: 22010: 22011: 12012: 22013: 22014: 32015: 42016: 32017: 22018: 32019: 12021: 12022: 32023: 22024: 12025: 1
1998high 4 (2015) · low 0 (1999)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 41 · See all
  • K970668The Amplantz Goose Neck MicrosnareMicrovena Corp. · 1998 · cites it directly40descendants
  • K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003 · 2 generations on32descendants
  • K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · 3 generations on31descendants
  • K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 4 generations on16descendants
  • K021606EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921649Retriever 10Target Therapeutics1993—
+1K970668The Amplantz Goose Neck MicrosnareMicrovena Corp.1998—
+2K022201Radius Micro SnareRadius Medical Technologies, Inc.2003—
+3K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc.2003—
+4K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps2008—
+2K021606EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200320
200421
200510
200810
200920
201021
201111
201220
201320
201430
201540
201630
201720
201830
201910
202110
202230
202320
202410
202510
FIG. 1 — Lineage of K921649, 1993–2025Source: 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.

3 devices in this family have a Class I recall. 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K970668The Amplantz Goose Neck MicrosnareMicrovena Corp.199840

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
  • K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K970668 (Microvena Corp., 1998) has gone furthest, with 40 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—
Cite this page

510(k) Report. “K921649: Retriever 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921649

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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