510(k) Report

510(k) · Cleared

Cleared

Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135

K062126510(k) SpecialCleared Aug 9, 200614-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

Biosphere Medical, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Aug 9, 2006 as substantially equivalent to K003105 (Biosphere Medical, 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.

Decided
Aug 9, 2006
Review
14 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003105 (2001). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK003105 · Biosphere Medical Infusion Catheter · Biosphere Medical · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K003105 · Biosphere Medical Infusion Catheter · Biosphere Medical · 20010+5
  1. Root · 1 generation backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
  2. This deviceK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
  3. Descendant · cites it directly · 9 of its ownK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
  4. Descendant · 2 generations on · 7 of its ownK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
  5. Descendant · 3 generations on · 6 of its ownK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
  6. Descendant · 4 generations on · 5 of its ownK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
  7. Descendant · 4 generations on · 4 of its ownK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22015: 12016: 12017: 12018: 12019: 12023: 12026: 1
2011high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K110459Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011 · cites it directly9descendants
  • K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012 · 2 generations on7descendants
  • K143588Surefire Infusion System 021Surefire Medical, Inc. · 2015 · 3 generations on6descendants
  • K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016 · 4 generations on5descendants
  • K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003105Biosphere Medical Infusion CatheterBiosphere Medical2001—
0 (this device)K062126Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc.2006—
+1K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.2011—
+2K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc.2012—
+3K143588Surefire Infusion System 021Surefire Medical, Inc.2015—
+4K160662Surefire Infusion SystemSurefire Medical, Inc.2016—
+4K171355Surefire Precision Infusion SystemSurefire Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201510
201610
201710
201810
201910
202310
202610
FIG. 1 — Lineage of K062126, 2001–2026Source: 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 DQO? 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
Get a 510(k) Report

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
*K003105Biosphere Medical Infusion Catheter
Summary page 1
…lassification Name: Catheter Intravascular Diagnostic (21CFR 870.1200, DQO) 3. PREDICATE DEVICES * EmboCath Hydrophilic Catheter (K003105) 4. DEVICE DESCRIPTION The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCa…
Biosphere Medical2001—

Also cleared against K003105: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.20119

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?

  • Its one ancestor has no recall.
  • Of its descendants, K110459 (Surefire Medical, Inc., 2011) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K003105.

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)—

What is it indicated for?

The EmboCath® Plus Infusion Microcatheter is intended for:

infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

Indications for use as stated in the FDA summary.

Also cleared against K003105

1 other device cites the same predicate.

  • K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005

More from Biosphere Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K113822Quadrasphere 30 to 60Biosphere Medical, Inc. · 2012
  • K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
  • K061171Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc. · 2006
  • K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 2002
  • K010026Embogold MicrosphereBiosphere Medical, Inc. · 2001

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K062126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062126: Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062126

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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