510(k) Report

510(k) · Cleared

Cleared

Soaker Catheter

K994374510(k) TraditionalCleared Mar 3, 200067-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

I-Flow Corp. · FRN Pump, Infusion

Cleared on Mar 3, 2000 as substantially equivalent to K991543 (I-Flow Corp., 1999) and 3 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1981. 18 later devices descend from it.

Decided
Mar 3, 2000
Review
67 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K813186 (1981). 4 ancestors in all. 18 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1984: 1 other ancestor2019: 1 descendant cleared2005: 2 descendants cleared2006: 3 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2008: 2 descendants cleared2014: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2016: 2 descendants cleared2020: 2 descendants clearedK813186 · Perfix Set for Epidural Anesthesia W/Tuo · Burron Medical Products, Inc. · 1981K991543 · Intraop Catheter · I-Flow Corp. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants K991543 · Intraop Catheter · I-Flow Corp. · 1999K813186 · Perfix Set for Epidural Anesthesia W/Tuo · Burron Medical Products, Inc. · 19810
  1. Root · 2 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
  2. 1 generation backK991543 Intraop CatheterI-Flow Corp. · 1999
  3. This deviceK994374 Soaker CatheterI-Flow Corp. · 2000
  4. Descendant · cites it directly · 12 of its ownK022869 Soaker CatheterI-Flow Corp. · 2002
  5. Descendant · cites it directly · 11 of its ownK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
  6. Descendant · 2 generations on · 4 of its ownK143164 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014
  7. Descendant · 2 generations on · 4 of its ownK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
  8. Descendant · 2 generations on · 2 of its ownK080675 Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 22006: 32008: 22011: 12014: 12016: 22017: 12019: 12020: 2
2002high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 18 · See all
  • K022869Soaker CatheterI-Flow Corp. · 2002 · cites it directly12descendants
  • K043456Modification to Soaker CatheterI-Flow Corp. · 2005 · cites it directly11descendants
  • K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014 · 2 generations on4descendants
  • K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005 · 2 generations on4descendants
  • K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K813186Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc.1981—
−1K991543Intraop CatheterI-Flow Corp.1999—
0 (this device)K994374Soaker CatheterI-Flow Corp.2000—
+1K022869Soaker CatheterI-Flow Corp.2002—
+1K043456Modification to Soaker CatheterI-Flow Corp.2005—
+2K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation2014—
+2K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp.2005—
+2K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200520
200630
200820
201110
201410
201620
201710
201910
202020
FIG. 1 — Lineage of K994374, 1981–2020Source: 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 FRN? 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 FRN device

  1. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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
*K991543Intraop Catheter
Summary page 1
…2700 Fax: 949.206.2600 1.0 GENERAL INFORMATION 1.1 Statement of Equivalence 1.1.1 The Soaker Catheter is substantially equivalent to the (1) |-Flow IntraOp Catheter (K991543), (2) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries), (3) B. Braun Perifix Set (K813186) and…
I-Flow Corp.1999—
*K840202Epidural Catheter
Summary page 1
…tement of Equivalence 1.1.1 The Soaker Catheter is substantially equivalent to the (1) |-Flow IntraOp Catheter (K991543), (2) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries), (3) B. Braun Perifix Set (K813186) and (4) the Epimed International FETH-R_KATH catheter (K9813…
Aries Medical, Inc.1984—
*K813186Perfix Set for Epidural Anesthesia W/Tuo
Summary page 1
…quivalent to the (1) |-Flow IntraOp Catheter (K991543), (2) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries), (3) B. Braun Perifix Set (K813186) and (4) the Epimed International FETH-R_KATH catheter (K981329). 1.1.2 The Soaker Catheter package may inciude components that…
Burron Medical Products, Inc.1981—
*K981329Feth-R-Kath
Summary page 1
…flex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries), (3) B. Braun Perifix Set (K813186) and (4) the Epimed International FETH-R_KATH catheter (K981329). 1.1.2 The Soaker Catheter package may inciude components that are legally marketed (either pre-amendment devices or devices t…
Epimed International, Inc.19982

Also cleared against K991543: 4 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K022869Soaker CatheterI-Flow Corp.200212
K043456Modification to Soaker CatheterI-Flow Corp.200511
K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041
K191470C-CAT Anaesthesia Catheter kitCimpax Aps20190
K060119Mckinley Saturation CatheterMckinley Medical, LLC20060
K024190Fenestrated Infusion CatheterPromedic, Inc.20030

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 19 years and passes through 2 companies; a new generation was cleared every 17.9 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K022869 (I-Flow Corp., 2002) has gone furthest, with 12 descendants of its own.
  • 4 other devices also cite its predicate K991543.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The Soaker Catheter is intended to be used as follows:

1. With I-Flow Corporation’s PainBuster, ON-Q and Nerve Block pain management kits; and

2. As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K991543

4 other devices cite the same predicate.

  • K081404Spinal Integration Spinal-Eze Intraoperative Epidural Catheter KitSpinal Integration, LLC · 2008
  • K043456Modification to Soaker CatheterI-Flow Corp. · 2005
  • K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
  • K022869Soaker CatheterI-Flow Corp. · 2002

More from I-Flow Corp.

41 FDA decisions under this applicant name. See the company

  • K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, EasypumpI-Flow Corp. · 20073 recalls
  • K063234ON-Q IntroducersI-Flow Corp. · 2006
  • K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005
  • K052117I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)I-Flow Corp. · 20053 recalls
  • K043456Modification to Soaker CatheterI-Flow Corp. · 2005

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K994374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994374: Soaker Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994374

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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