510(k) Report

510(k) · Cleared

Cleared

Biosphere Medical Infusion Catheter

K003105510(k) TraditionalCleared May 22, 2001230-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 · DQO Catheter, Intravascular, Diagnostic

Cleared on May 22, 2001 after a 230-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided
May 22, 2001
Review
230 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

31 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2005: 3 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2007: 1 descendant cleared2015: 1 descendant cleared2008: 3 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 4 descendants cleared2023: 1 descendant cleared2026: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2020: 2 descendants cleared200020052010201520202025
  1. This deviceK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
  2. Descendant · cites it directly · 19 of its ownK041826 Ekos Ultrasound Infusion SystemEkos Corp. · 2005
  3. Descendant · 2 generations on · 18 of its ownK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
  4. Descendant · 3 generations on · 16 of its ownK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
  5. Descendant · 3 generations on · 16 of its ownK053432 Ekos Micro-Infusion SystemEkos Corp. · 2005
  6. Descendant · 4 generations on · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2005: 32006: 42007: 12008: 32011: 22012: 22015: 12016: 12017: 12018: 12019: 42020: 22021: 12023: 12024: 12026: 3
2005high 4 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005 · cites it directly19descendants
  • K051225Ekos Micro-Infusion SystemEkos Corp. · 2005 · 2 generations on18descendants
  • K053437Ekos Micro-Infusion SystemEkos Corp. · 2006 · 3 generations on16descendants
  • K053432Ekos Micro-Infusion SystemEkos Corp. · 2005 · 3 generations on16descendants
  • K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · 4 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003105Biosphere Medical Infusion CatheterBiosphere Medical2001—
+1K041826Ekos Ultrasound Infusion SystemEkos Corp.2005—
+2K051225Ekos Micro-Infusion SystemEkos Corp.2005—
+3K053437Ekos Micro-Infusion SystemEkos Corp.2006—
+3K053432Ekos Micro-Infusion SystemEkos Corp.2005—
+4K062508Neurowave Micro-Infusion SystemEkos Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200640
200710
200830
201120
201220
201510
201610
201710
201810
201940
202020
202110
202310
202410
202630
FIG. 1 — Lineage of K003105, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K041826Ekos Ultrasound Infusion SystemEkos Corp.200519
K062126Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc.200610

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?

  • Of its descendants, K041826 (Ekos Corp., 2005) has gone furthest, with 19 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)—

More from Biosphere Medical

2 FDA decisions under this applicant name. See the company

  • K991549Embosphere MicrospheresBiosphere Medical · 2000

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/K003105 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003105: Biosphere Medical Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003105

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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