510(k) Report

510(k) · Cleared

Cleared

Solopicc 24 (60CM) 20GA Catheter

K954428510(k) TraditionalCleared Mar 28, 1996188-day reviewClass II21 CFR 880.5200

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

Douglas Medical Products Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Mar 28, 1996 as substantially equivalent to K801575 (Luther Medical Products, Inc., 1980) and 1 other predicate after a 188-day review. Its family tree reaches back 1 generation to 1980.

Decided
Mar 28, 1996
Review
188 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K801575 (1980). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestorK801575 · L-Cath Intravenous Placement Unit · Luther Medical Products, Inc. · 19801980198519901995
Other ancestors, by generation 1 generation back: 1 other ancestor K801575 · L-Cath Intravenous Placement Unit · Luther Medical Products, Inc. · 19800
  1. Root · 1 generation backK801575 L-Cath Intravenous Placement UnitLuther Medical Products, Inc. · 1980
  2. This deviceK954428 Solopicc 24 (60CM) 20GA CatheterDouglas Medical Products Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K801575L-Cath Intravenous Placement UnitLuther Medical Products, Inc.1980—
0 (this device)K954428Solopicc 24 (60CM) 20GA CatheterDouglas Medical Products Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
FIG. 1 — Lineage of K954428, 1980–1996Source: 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 FOZ? 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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? (2)

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
*K801575L-Cath Intravenous Placement Unit
Summary page 1
…the predicate devices named in this submission. The named predicate devices in this submission were the Luther Medical Products, Inc. L-Cath® Intravenous Placement Unit (K801575) and the Medical Profiles, Inc. Peripheral Intravenous Catheter (K914378). The SoloPICC and SoloMidline catheters are sterilized…
Luther Medical Products, Inc.1980—
*K914378Peripheral Intervenous Catheter
Summary page 1
…es in this submission were the Luther Medical Products, Inc. L-Cath® Intravenous Placement Unit (K801575) and the Medical Profiles, Inc. Peripheral Intravenous Catheter (K914378). The SoloPICC and SoloMidline catheters are sterilized per AAMI guidelines to a 10 6 sterility assurance level. Each production…
Medical Profiles, Inc.1993—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

What is it indicated for?

The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

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

More from Douglas Medical Products Corp.

19 FDA decisions under this applicant name. See the company

  • K961155Solo Picc/Midline Catheter Kit Models 71924, 71908Douglas Medical Products Corp. · 1996
  • K94162840 Micron Blood Transfusion FilterDouglas Medical Products Corp. · 1995
  • K9421014-Lead Irrigation SetDouglas Medical Products Corp. · 1994
  • K941453Check Valve Solution SetDouglas Medical Products Corp. · 1994
  • K930854Solution Set with .2 Micron FilterDouglas Medical Products Corp. · 1994

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K954428 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954428: Solopicc 24 (60CM) 20GA Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954428

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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