510(k) Report

510(k) · Cleared

Cleared

Rinspiration System

K031485510(k) TraditionalCleared Sep 25, 2003136-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

Kerberos Proximal Solutions · DQO Catheter, Intravascular, Diagnostic

Cleared on Sep 25, 2003 as substantially equivalent to K974067 (Merit Medical Systems, Inc., 1998) and 3 other predicates after a 136-day review. Its family tree reaches back 3 generations to 1990. 19 later devices descend from it.

Decided
Sep 25, 2003
Review
136 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K904788 (1990). 6 ancestors in all, the oldest K873004 (1987). 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1987: 1 other ancestor1996: 1 other ancestor2004: 2 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK904788 · Mewissen Catheter · Boston Scientific Corp · 1990×2: 2 generations cleared close together, K974067 (1998), K981417 (1998) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants K981417 · Squirt Fluid Delivery System · Merit Medical Systems, Inc. · 1998K974067 · Fountain Infusion Catheter and Occluding Guide Wire · Merit Medical Systems, Inc. · 1998 · recalledK904788 · Mewissen Catheter · Boston Scientific Corp · 19900+5
  1. Root · 3 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 2 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
  3. 1 generation backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
  4. This deviceK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
  5. Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  6. Descendant · cites it directly · 17 of its ownK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
  7. Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  8. Descendant · 3 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  9. Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12006: 12007: 22008: 22012: 22014: 12016: 12017: 12018: 12020: 22023: 12025: 12026: 1
2004high 2 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
  • K041291Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 3 generations on9descendants
  • K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K904788Mewissen CatheterBoston Scientific Corp1990—
−2K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199823
−1K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.1998—
0 (this device)K031485Rinspiration SystemKerberos Proximal Solutions2003—
+1K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+1K041291Rinspiration SystemKerberos Proximal Solutions, Inc.2004—
+2K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+3K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—
+3K080901Lbi Embolectomy SystemLumen Biomedical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200610
200720
200820
201220
201410
201610
201710
201810
202020
202310
202510
202610
FIG. 1 — Lineage of K031485, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K974067Fountain Infusion Catheter and Occluding Guide Wire
Summary page 1
…redicate Device: The subject device is substantially equivalent in intended use andor method of operation to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheta (K873004) and the OriGen Dual Lumen Catheter (K003288). Intended Use: The KPS Rinspir…
Merit Medical Systems, Inc.199823
*K981417Squirt Fluid Delivery System
Summary page 1
…Device: The subject device is substantially equivalent in intended use andor method of operation to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheta (K873004) and the OriGen Dual Lumen Catheter (K003288). Intended Use: The KPS RinspirationTMS…
Merit Medical Systems, Inc.1998—
*K873004Guiding Catheter
Summary page 1
…equivalent in intended use andor method of operation to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheta (K873004) and the OriGen Dual Lumen Catheter (K003288). Intended Use: The KPS RinspirationTMSyste:m is intended to infuse and aspirate in…
Mallinckrodt Critical Care1987—
*K003288Origen Dual Lumen Catheter
Summary page 1
…peration to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheta (K873004) and the OriGen Dual Lumen Catheter (K003288). Intended Use: The KPS RinspirationTMSyste:m is intended to infuse and aspirate in the peripheral vasculature. Device Descript…
Origen Biomedical, Inc.2001—

Also cleared against K974067: 5 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417
K041291Rinspiration SystemKerberos Proximal Solutions, Inc.200417

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 13 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K041123 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 17 descendants of its own.
  • 5 other devices also cite its predicate K974067.

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 KPS Rinspira'tionTM System is intended to infuse and aspirate in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K974067

5 other devices cite the same predicate.

  • K193082Fountain ValveTip Infusion CatheterMerit Medical Systems, Inc. · 2020
  • K041629Lysus Infusion SystemEkos Corp. · 2004
  • K992231FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 19992 recalls
  • K991619FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1999
  • K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998

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/K031485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031485: Rinspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031485

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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