510(k) Report

510(k) · Cleared

Cleared

Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310

K032484510(k) TraditionalCleared Oct 28, 200377-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

Medtronic Minimed · FPA Set, Administration, Intravascular

Cleared on Oct 28, 2003 as substantially equivalent to K002138 (Maersk Medical A/S, 2000) after a 77-day review. Its family tree reaches back 1 generation to 2000.

Decided
Oct 28, 2003
Review
77 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002138 (2000). No later device cites it as a predicate yet.

K002138 · Paradigm Silhouette, Models MMT-377, 378, 379, 380 · Maersk Medical A/S · 2000 · recalled200020022004
K002138 · Paradigm Silhouette, Models MMT-377, 378, 379, 380 · Maersk Medical A/S · 2000 · recalled0
  1. Root · 1 generation backK002138 Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S · 2000 · Recalled
  2. This deviceK032484 Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310Medtronic Minimed · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002138Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S20002
0 (this device)K032484Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310Medtronic Minimed2003—
FIG. 1 — Lineage of K032484, 2000–2003Source: 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 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
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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
*K002138Paradigm Silhouette, Models MMT-377, 378, 379, 380
Summary page 1
…m Countach Infusion set Model MMT-3 10 Predicate Devices: Maersk M d c a l A / S Paradigm Silhouette Ifision sets Models MMT-377. 378. 379,380 (Prenlarket notification K002138) Description of the Device: The Medtronic MiniMed Paradigm Countach f i s i o n set Model MMT- 3 10 is a dlsposable. single-use…
Maersk Medical A/S20002

Also cleared against K002138: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K002138.

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 Paradigm Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an infusion pump and reservoir. The set is not intended nor indicated for use with blood or blood products.

Indications for use as stated in the FDA summary.

Also cleared against K002138

1 other device cites the same predicate.

  • K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 20164 recalls

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491 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K032484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032484: Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032484

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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