510(k) Report

510(k) · Cleared

Cleared

Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models

K033372510(k) TraditionalCleared Jan 9, 200479-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

Micro Therapeutics, Inc. · HCG Device, Neurovascular Embolization

Cleared on Jan 9, 2004 as substantially equivalent to K031852 (Micro Therapeutics, Inc., 2003) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1990. 29 later devices descend from it.

Decided
Jan 9, 2004
Review
79 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K901337 (1990). 3 ancestors in all. 29 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2004: 1 descendant cleared2007: 1 descendant cleared2005: 3 descendants cleared2006: 1 descendant cleared2015: 3 descendants cleared2008: 1 descendant cleared2017: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants cleared2014: 3 descendants cleared2021: 2 descendants cleared2018: 3 descendants cleared2026: 2 descendants cleared2023: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2019: 1 descendant clearedK901337 · Hilal Embolization Microcoil (TM) · Cook, Inc. · 1990 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants K901337 · Hilal Embolization Microcoil (TM) · Cook, Inc. · 1990 · recalled0+5
  1. Root · 1 generation backK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990 · Recalled
  2. This deviceK033372 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone…Micro Therapeutics, Inc. · 2004
  3. Descendant · cites it directly · 28 of its ownK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
  4. Descendant · 2 generations on · 27 of its ownK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
  5. Descendant · 3 generations on · 24 of its ownK051560 Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
  6. Descendant · 3 generations on · 24 of its ownK051425 Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
  7. Descendant · 2 generations on · 23 of its ownK060747 FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · Recalled

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 12007: 12008: 12009: 12013: 22014: 32015: 32017: 12018: 32019: 12020: 12021: 22022: 22023: 12026: 2
2004high 3 (2005) · low 0 (2010)2026

Most influential descendants

Showing 5 of 29 · See all
  • K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004 · cites it directly28descendants
  • K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005 · 2 generations on27descendants
  • K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 3 generations on24descendants
  • K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 3 generations on24descendants
  • K060747FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901337Hilal Embolization Microcoil (TM)Cook, Inc.19902
0 (this device)K033372Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsMicro Therapeutics, Inc.2004—
+1K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc.2004—
+2K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc.2005—
+3K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc.2005—
+3K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc.2005—
+2K060747FX Detachable Coil SystemMicro Therapeutics, Inc.20072

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200610
200710
200810
200910
201320
201430
201530
201710
201830
201910
202010
202120
202220
202310
202620
FIG. 1 — Lineage of K033372, 1990–2026Source: 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), 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 HCG? 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? (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
*K031852Sapphire Detachable Fiber Coils
Summary page 1
…vine, California 92618 Contact: Florin Truuvert Predicate Device: Number Description Clearance Date K031852 MTI Sapphire Detachable Fibered Coil System August 20, 2003 K030392 MTI Sapphire Detachable Co…
Micro Therapeutics, Inc.2003—
*K030392Sapphire Detachable Coil System
Summary page 1
…Description Clearance Date K031852 MTI Sapphire Detachable Fibered Coil System August 20, 2003 K030392 MTI Sapphire Detachable Coil System July 21, 2003 K901337 Cook, Inc. Hilal Embolizatio…
Micro Therapeutics, Inc.2003—
*K901337Hilal Embolization Microcoil (TM)
Summary page 1
…MTI Sapphire Detachable Fibered Coil System August 20, 2003 K030392 MTI Sapphire Detachable Coil System July 21, 2003 K901337 Cook, Inc. Hilal Embolization Microcoil November 13, 1990 Device Description The Sapphire Detachable F…
Cook, Inc.19902

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc.200428

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K041649 (Micro Therapeutics, Inc., 2004) has gone furthest, with 28 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—

What is it indicated for?

The Sapphire Detachable Fibered Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Indications for use as stated in the FDA summary.

More from Micro Therapeutics, Inc.

51 FDA decisions under this applicant name. See the company

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls

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/K033372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033372: Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033372

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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