510(k) Report

510(k) · Cleared

Cleared

Contour Emboli

K944354510(k) TraditionalCleared Dec 13, 1994105-day reviewClass II21 CFR 882.5950

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

Interventional Therapeutics Corp. · HCG Device, Neurovascular Embolization

Cleared on Dec 13, 1994 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 58 devices in its family, counting itself, has a Class I recall. 57 later devices descend from it.

Decided
Dec 13, 1994
Review
105 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
0

57 later devices descend from it, 7 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 2 descendants cleared2006: 2 descendants cleared2003: 1 descendant cleared1998: 2 descendants cleared1997: 1 descendant cleared2000: 1 descendant cleared2004: 2 descendants cleared2010: 2 descendants cleared2008: 3 descendants cleared2014: 4 descendants cleared2012: 2 descendants cleared2015: 2 descendants cleared2002: 1 descendant cleared2018: 6 descendants cleared2022: 3 descendants cleared, 1 with a Class I recall12016: 2 descendants cleared2017: 2 descendants cleared2013: 3 descendants cleared2023: 1 descendant cleared2024: 5 descendants cleared2019: 4 descendants cleared2025: 4 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK944354 Contour EmboliInterventional Therapeutics Corp. · 1994
  2. Descendant · cites it directly · 52 of its ownK991549 Embosphere MicrospheresBiosphere Medical · 2000
  3. Descendant · 2 generations on · 41 of its ownK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
  4. Descendant · cites it directly · 18 of its ownK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
  5. Descendant · cites it directly · 11 of its ownK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
  6. Descendant · 2 generations on · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22000: 12002: 12003: 12004: 22005: 22006: 22008: 32010: 22012: 22013: 32014: 42015: 22016: 22017: 22018: 62019: 42021: 12022: 32023: 12024: 52025: 42026: 1
1997high 6 (2018) · low 0 (1999)2026

Class I recalls in this family

  • K213385 GEM5 generations on · 2022

Most influential descendants

Showing 5 of 57 · See all
  • K991549Embosphere MicrospheresBiosphere Medical · 2000 · cites it directly52descendants
  • K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 2002 · 2 generations on41descendants
  • K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · cites it directly18descendants
  • K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006 · cites it directly11descendants
  • K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944354Contour EmboliInterventional Therapeutics Corp.1994—
+1K991549Embosphere MicrospheresBiosphere Medical2000—
+2K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid…Biosphere Medical, Inc.2002—
+1K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp20031
+1K052742Hepasphere MicrospheresBiosphere Medical, Inc.2006—
+2K034068Contour SE MicrospheresBoston Scientific Corp2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200010
200210
200310
200420
200520
200620
200830
201020
201220
201330
201440
201520
201620
201720
201860
201940
202110
202231
202310
202450
202540
202610
FIG. 1 — Lineage of K944354, 1994–2026Source: 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.

1 device in this family has 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 HCG device

  1. #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K991549Embosphere MicrospheresBiosphere Medical200052
K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp200318
K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611
K965174Trufill Pva ParticlesCordis Neurovascular, Inc.19971
K042297Ultra Ivalon and Ultra Drivalon Pva Embolization ParticlesActa Vascular Systems, Inc.20050
K964488Detachable Silicone Balloon (DSB)Target Therapeutics19980
K965071Detachable Slicone Balloon (DSB)Target Therapeutics19980

Has anything in its family been recalled? (1 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.

  • K213385GEMObsidio, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K991549 (Biosphere Medical, 2000) has gone furthest, with 52 descendants of its own.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCG

3in 2025

2007: 82008: 92009: 72010: 82011: 92012: 72013: 72014: 52015: 52016: 72017: 52018: 42019: 12020: 22021: 52022: 32023: 22024: 42025: 32026 (partial year): 4
2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007: 50 days median2008: 71 days median2009: 48 days median2010: 72 days median2011: 78 days median2012: 30 days median2013: 67 days median2014: 66 days median2015: 60 days median2016: 37 days median2017: 97 days median2018: 173 days median2021: 103 days median2022: 114 days median2024: 49 days median2025: 107 days median2026 (partial year): 30 days median
2007high 173 (2018) · low 30 (2012)2026

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

Recalls per year · HCG

1in 2025

2007: 12008: 32010: 22011: 12013: 22014: 42022: 22024: 12025: 1, 1 Class I2026 (partial year): 1
2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007: 3262008: 7302009: 8212010: 8512011: 8942012: 1,1462013: 1,1032014: 1,7292015: 1,5982016: 1,9912017: 2,4942018: 2,0582019: 1,7632020: 1,7542021: 2,2682022: 6632023: 5682024: 5522025: 537
2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, 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
20078501326
20089713730
20097480821
20108722851
20119781894
201273001,146
201376721,103
201456641,729
201556001,598
201673701,991
201759702,494
2018417302,058
20191—01,763
20202—01,754
2021510302,268
202231142663
20232—0568
20244491552
202531071 (1)537
20264301—

More from Interventional Therapeutics Corp.

28 FDA decisions under this applicant name. See the company

  • K960832Occlusion Balloon CatheterInterventional Therapeutics Corp. · 1996
  • K950398Catheter, Balloon TypeInterventional Therapeutics Corp. · 1995
  • K945588Disposable 1CC Syringe with Luer LockInterventional Therapeutics Corp. · 1995
  • K930456Intherm Single-Stick Radially Expanding DilatorInterventional Therapeutics Corp. · 1993
  • K914866Itc Contour Emboli, ModificationInterventional Therapeutics Corp. · 1993

Recent decisions in HCG

The HCG category page

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K261772Target Xtra Detachable CoilStryker Neurovscular · 2026
  • K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
  • K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025

https://510kreport.com/device/K944354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944354: Contour Emboli.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944354

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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