510(k) Report

510(k) · Cleared

Cleared

Paragon Infusion System

K020251510(k) SpecialCleared Feb 15, 200222-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 Feb 15, 2002 as substantially equivalent to K923875 (I-Flow Corp., 1993) and 5 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1990. 1 of the 22 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided
Feb 15, 2002
Review
22 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K896422 (1990). 13 ancestors in all, the oldest K890489 (1989). 8 later devices descend from it, 3 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1996: 1 other ancestor1993: 2 other ancestors1989: 2 other ancestors1995: 2 other ancestors2005: 1 descendant cleared2002: 2 descendants cleared2008: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedK896422 · Burron Ambulatory Drug Delivery System · Burron Medical, Inc. · 1990K980558 · Painbuster Infusion System · I-Flow Corp. · 1998×2: 2 generations cleared close together, K982946 (1998), K984146 (1999) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant, 1 with a Class I recall13 generations forward: 1 descendant4 generations forward: 3 descendants K984146 · Paragon Infusion · I-Flow Corp. · 1999K982946 · Painbuster Infusion Kit · I-Flow Corp. · 1998K980558 · Painbuster Infusion System · I-Flow Corp. · 1998K896422 · Burron Ambulatory Drug Delivery System · Burron Medical, Inc. · 19900
  1. Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
  2. 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
  3. 2 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
  4. 1 generation backK984146 Paragon InfusionI-Flow Corp. · 1999
  5. This deviceK020251 Paragon Infusion SystemI-Flow Corp. · 2002
  6. Descendant · cites it directly · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
  7. Descendant · 2 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
  8. Descendant · 3 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
  9. Descendant · 4 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
  10. Descendant · 4 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 22005: 12008: 12016: 12024: 22026: 1
2002high 2 (2002) · low 0 (2003)2026

Class I recalls in this family

  • K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations on · 2008

Most influential descendants

Showing 5 of 8 · See all
  • K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · cites it directly5descendants
  • K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on4descendants
  • K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 3 generations on3descendants
  • K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 4 generations on0descendants
  • K240624InfuLifeFirst Medical Source, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K896422Burron Ambulatory Drug Delivery SystemBurron Medical, Inc.1990—
−3K980558Painbuster Infusion SystemI-Flow Corp.1998—
−2K982946Painbuster Infusion KitI-Flow Corp.1998—
−1K984146Paragon InfusionI-Flow Corp.1999—
0 (this device)K020251Paragon Infusion SystemI-Flow Corp.2002—
+1K052451MPS Acacia Medflo Elastomeric PumpMps Acacia2005—
+2K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.2008Class I
+3K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.2016—
+4K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.2026—
+4K240624InfuLifeFirst Medical Source, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199320
199520
199610
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200510
200811
201610
202420
202610
FIG. 1 — Lineage of K020251, 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.

1 device in this family has a Class I recall. 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? (6)

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
*K923875Sidekick 50 Plus and Sidekick 100 Plus
Summary page 1
…0 Shane Noehre Manager of Regulatory Affairs [-Flow Corporation Paragon Infusion System Infusion Pump and Administration Set Pump, Infusion Paragon Infusion System (K923875, K984146, K984063, K984638) The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of sin…
I-Flow Corp.19931
*K984146Paragon Infusion
Summary page 1
…Noehre Manager of Regulatory Affairs [-Flow Corporation Paragon Infusion System Infusion Pump and Administration Set Pump, Infusion Paragon Infusion System (K923875, K984146, K984063, K984638) The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use a…
I-Flow Corp.1999—
*K984063Paragon Basal/Bolus Administration Set
Summary page 1
…nager of Regulatory Affairs [-Flow Corporation Paragon Infusion System Infusion Pump and Administration Set Pump, Infusion Paragon Infusion System (K923875, K984146, K984063, K984638) The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use administra…
I-Flow Corp.1999—
*K984638Paragon Bolus Accessory Set
Summary page 1
…Regulatory Affairs [-Flow Corporation Paragon Infusion System Infusion Pump and Administration Set Pump, Infusion Paragon Infusion System (K923875, K984146, K984063, K984638) The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use administration sets…
I-Flow Corp.1999—
*K960318Dib Infusor-RA
Summary page 1
…same technology for regulating flow rate (i.e. flow control tubing) and similar devices with variable flow rate components exist in the market {Novacon DIB-Infusor-RA — K960318 and Baxter Flow Regulator — K890489). Conclusion: The Paragon Infusion System is substantially equivalent to the existing Parag…
Novacon Corp.1996—
*K890489Extension Set W/Flow Regulator
Summary page 1
…rate (i.e. flow control tubing) and similar devices with variable flow rate components exist in the market {Novacon DIB-Infusor-RA — K960318 and Baxter Flow Regulator — K890489). Conclusion: The Paragon Infusion System is substantially equivalent to the existing Paragon Infusion System and other variable…
Baxter Healthcare Corp1989—

Also cleared against K923875: 5 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055
K023883Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, KvoI-Flow Corp.20020
K020660Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step KvoI-Flow Corp.20020

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K052451 (Mps Acacia, 2005) has gone furthest, with 5 descendants of its own.
  • 5 other devices also cite its predicate K923875.

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 Paragon Infusion System is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.

The Paragon Infusion System is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. 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 K923875

5 other devices cite the same predicate.

  • K052817Eureka Infusion Pump, Models Eureka-IP, Eureka-LFUniversal Medical Technologies · 2006
  • K990425Sidekick Infusion KitI-Flow Corp. · 1999
  • K984146Paragon InfusionI-Flow Corp. · 1999
  • K984063Paragon Basal/Bolus Administration SetI-Flow Corp. · 1999
  • K963355Solopak Paragon Infusor Pump and Infusion SetSolopak Medical Products, Inc. · 1996

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/K020251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020251: Paragon Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020251

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