510(k) Report

510(k) · Cleared

Cleared

Simplicity Easy Access Infusion Set

K014062510(k) AbbreviatedCleared Jan 17, 200238-day reviewClass II21 CFR 880.5440

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

Sterling Medivations, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 17, 2002 as substantially equivalent to K972135 (P/L Biomedical, 1997) after a 38-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.

Decided
Jan 17, 2002
Review
38 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972135 (1997). 3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 3 descendants clearedK972135 · Maersk Medical Pureline Comfort Subcutaneous Infusion Set · P/L Biomedical · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant K972135 · Maersk Medical Pureline Comfort Subcutaneous Infusion Set · P/L Biomedical · 1997 · recalled0
  1. Root · 1 generation backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
  2. This deviceK014062 Simplicity Easy Access Infusion SetSterling Medivations, Inc. · 2002
  3. Descendant · cites it directly · 1 of its ownK020912 Simplicity Easy Soft Infusion SetSterling Medivations, Inc. · 2002
  4. Descendant · 2 generations on · 0 of its ownK021530 Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of…Sterling Medivations, Inc. · 2002
  5. Descendant · cites it directly · 0 of its ownK021487 Simplicity Easy Access P Infusion SetSterling Medivations, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K020912Simplicity Easy Soft Infusion SetSterling Medivations, Inc. · 2002 · cites it directly1descendant
  • K021530Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the…Sterling Medivations, Inc. · 2002 · 2 generations on0descendants
  • K021487Simplicity Easy Access P Infusion SetSterling Medivations, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972135Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical199716
0 (this device)K014062Simplicity Easy Access Infusion SetSterling Medivations, Inc.2002—
+1K020912Simplicity Easy Soft Infusion SetSterling Medivations, Inc.2002—
+2K021530Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids…Sterling Medivations, Inc.2002—
+1K021487Simplicity Easy Access P Infusion SetSterling Medivations, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
FIG. 1 — Lineage of K014062, 1997–2002Source: 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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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
*K972135Maersk Medical Pureline Comfort Subcutaneous Infusion Set
Summary page 1
…n Name of Device: Intravascular administration set. Classification Name: Percutaneous intravascular catheter. Predicate Device: Medical Pureline™ Comfort™ Infusion Set, K972135. Description of the New Device: Sterling Medivations Inc.’s (“SMI”) Simplicity Easy Access Infusion Set is designed for infusion…
P/L Biomedical199716

Also cleared against K972135: 7 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K020912Simplicity Easy Soft Infusion SetSterling Medivations, Inc.20021
K021487Simplicity Easy Access P Infusion SetSterling Medivations, Inc.20020

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?

  • Its one ancestor has a recall.
  • Of its descendants, K020912 (Sterling Medivations, Inc., 2002) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K972135.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The intended use of the Simplicity Easy Access Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

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 K972135

7 other devices cite the same predicate.

  • K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 20173 Class I recalls
  • K061374Intuition Infusion SetsUnomedical A/S · 2006
  • K051264Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsUnomedical A/S · 20051 recall
  • K041545Contact DetachUnomedical A/S · 20043 recalls
  • K032485Medtronic Minimed Countach Infusion Set, Model 313Medtronic Minimed · 2003
  • K032854Unomedical Monica Infusion SetUnomedical A/S · 20031 recall

More from Sterling Medivations, Inc.

27 FDA decisions under this applicant name. See the company

  • K021530Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface…Sterling Medivations, Inc. · 2002
  • K021487Simplicity Easy Access P Infusion SetSterling Medivations, Inc. · 2002
  • K021296Simplicity QD Easy P Infusion SetSterling Medivations, Inc. · 2002
  • K021216Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion PumpsSterling Medivations, Inc. · 2002
  • K021005Simplicity Easy Access II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the SurfaceSterling Medivations, Inc. · 2002

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K014062 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014062: Simplicity Easy Access Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014062

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026