510(k) Report

510(k) · Cleared

Cleared

Maclin Power Intravascular Administration Set

K121511510(k) TraditionalCleared Mar 7, 2013290-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

Maclin Power, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 7, 2013 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) and 3 other predicates after a 290-day review. Its family tree reaches back 2 generations to 1999. 1 of the 7 devices in its family, counting itself, has a Class I recall.

Decided
Mar 7, 2013
Review
290 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K984381 (1999). 6 ancestors in all, the oldest K925465 (1993). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2005: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestorK984381 · Buretrol Solution Sets · Baxter Healthcare Corp · 1999 · Class I recallK023595 · Burette-in Line (150 ML) · Tuta Healthcare Pty Limited · 2002199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K023595 · Burette-in Line (150 ML) · Tuta Healthcare Pty Limited · 2002K984381 · Buretrol Solution Sets · Baxter Healthcare Corp · 1999 · Class I recall0
  1. Root · 2 generations backK984381 Buretrol Solution SetsBaxter Healthcare Corp · 1999 · Recalled (Class I)
  2. 1 generation backK023595 Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 2002
  3. This deviceK121511 Maclin Power Intravascular Administration SetMaclin Power, Inc. · 2013

Class I recalls in this family

  • K984381 Buretrol Solution Sets2 generations back · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K984381Buretrol Solution SetsBaxter Healthcare Corp1999Class I
−1K023595Burette-in Line (150 ML)Tuta Healthcare Pty Limited2002—
0 (this device)K121511Maclin Power Intravascular Administration SetMaclin Power, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200110
200510
FIG. 1 — Lineage of K121511, 1999–2013Source: 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.

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 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? (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
*K970855Clave Connector
Summary page 1
…cular Administration Set, 21 CFR 880.5440, Class 11 0. Product Code: FPA LEGALLY MARKETED DEVICES (PREDICATE DEVICES) CLAVE Connector, ICU Medical Inc., K970855 VITALCARE I.V, ADMINISTRATION SET, VITALCARE GROUP, INC, K050906 BURETTE-IN LINE, TUTA HEALTHCARE PTY. K023595 INTRAVASCULAR IV S…
Icu Medical, Inc.199752
*K050906Vitalcare I.V. Administration Set
Summary page 1
…Code: FPA LEGALLY MARKETED DEVICES (PREDICATE DEVICES) CLAVE Connector, ICU Medical Inc., K970855 VITALCARE I.V, ADMINISTRATION SET, VITALCARE GROUP, INC, K050906 BURETTE-IN LINE, TUTA HEALTHCARE PTY. K023595 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, LIFEMED OF CALIFORNIA, K0…
Vitalcare Group, Inc.2005—
*K023595Burette-in Line (150 ML)
Summary page 1
…ES (PREDICATE DEVICES) CLAVE Connector, ICU Medical Inc., K970855 VITALCARE I.V, ADMINISTRATION SET, VITALCARE GROUP, INC, K050906 BURETTE-IN LINE, TUTA HEALTHCARE PTY. K023595 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, LIFEMED OF CALIFORNIA, K001329…
Tuta Healthcare Pty Limited2002—
*K001329Intravascular IV Set, IV Set with Burette, Extension Set
Summary page 1
…TRATION SET, VITALCARE GROUP, INC, K050906 BURETTE-IN LINE, TUTA HEALTHCARE PTY. K023595 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, LIFEMED OF CALIFORNIA, K001329 Section 5 rev 0 Page 5 -1 Macfin Power In…
Lifemed of California2001—

Also cleared against K970855: 14 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.

  • K984381Buretrol Solution SetsBaxter Healthcare Corp · 1999 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
  • 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
  • 14 other devices also cite its predicate K970855.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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 Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Indications for use as stated in the FDA summary.

Also cleared against K970855

14 other devices cite the same predicate.

  • K220267AMSafe NeuFlo Needleless ConnectorAmsino International, Inc. · 2022
  • K213004Needle Free ConnectorMedcaptain Life Science Co., Ltd. · 2022
  • K120799Arisure Neutral ValveYukon Medical, LLC · 2012
  • K100434Clave NeutronIcu Medical, Inc. · 20103 recalls
  • K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration Set ( StandardVictus, Inc. · 2010
  • K090189Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009

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/K121511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121511: Maclin Power Intravascular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121511

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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