510(k) Report

510(k) · Cleared

Cleared

Surefire HI-Flow Microcatheter

K121677510(k) TraditionalCleared Jun 14, 20127-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

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

Cleared on Jun 14, 2012 as substantially equivalent to K110459 (Surefire Medical, Inc., 2011) after a 7-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.

Decided
Jun 14, 2012
Review
7 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K003105 (2001). 5 ancestors in all, the oldest K915414 (1992). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor1992: 1 other ancestor2015: 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 · 2001K062126 · Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 · Biosphere Medical, Inc. · 2006K110459 · Surefire Infusion Catheter System · Surefire Medical, Inc. · 20111990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K110459 · Surefire Infusion Catheter System · Surefire Medical, Inc. · 2011K062126 · Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 · Biosphere Medical, Inc. · 2006K003105 · Biosphere Medical Infusion Catheter · Biosphere Medical · 20010+5
  1. Root · 3 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
  2. 2 generations backK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
  3. 1 generation backK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
  4. This deviceK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
  5. Descendant · cites it directly · 6 of its ownK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
  6. Descendant · 2 generations on · 5 of its ownK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
  7. Descendant · 2 generations on · 4 of its ownK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
  8. Descendant · 3 generations on · 2 of its ownK180677 Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
  9. Descendant · 4 generations on · 1 of its ownK230957 TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 12018: 12019: 12023: 12026: 1
2015high 1 (2015) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K143588Surefire Infusion System 021Surefire Medical, Inc. · 2015 · cites it directly6descendants
  • K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016 · 2 generations on5descendants
  • K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017 · 2 generations on4descendants
  • K180677Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018 · 3 generations on2descendants
  • K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003105Biosphere Medical Infusion CatheterBiosphere Medical2001—
−2K062126Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc.2006—
−1K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.2011—
0 (this device)K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc.2012—
+1K143588Surefire Infusion System 021Surefire Medical, Inc.2015—
+2K160662Surefire Infusion SystemSurefire Medical, Inc.2016—
+2K171355Surefire Precision Infusion SystemSurefire Medical, Inc.2017—
+3K180677Surefire Spark Infusion SystemSurefire Medical, Inc.2018—
+4K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201710
201810
201910
202310
202610
FIG. 1 — Lineage of K121677, 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
*K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.2011—

Also cleared against K110459: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K143588Surefire Infusion System 021Surefire Medical, Inc.20156

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K143588 (Surefire Medical, Inc., 2015) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K110459.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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 SUREFIRE' HI-FLOW MICROCATHETER is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Indications for use as stated in the FDA summary.

Also cleared against K110459

1 other device cites the same predicate.

  • K113737Surefire Guide SheathSurefire Medical, Inc. · 2012

More from Surefire Medical, Inc.

10 FDA decisions under this applicant name. See the company

  • K180677Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
  • K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
  • K162359Surefire Guiding CatheterSurefire Medical, Inc. · 2016
  • K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016
  • K143588Surefire Infusion System 021Surefire Medical, Inc. · 2015

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/K121677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121677: Surefire HI-Flow Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121677

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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