510(k) · Cleared
ClearedLuth-All Sub-Q Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luth-All Medical Products, LLC · FPA Set, Administration, Intravascular
Cleared on Dec 21, 2004 as substantially equivalent to K021565 (Luther Research Partners, 2002) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Dec 21, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K831445 (1983). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 2 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 1 generation backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- This deviceK042666 Luth-All Sub-Q Needle SetLuth-All Medical Products, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −2 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −1 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| 0 (this device) | K042666 | Luth-All Sub-Q Needle Set | Luth-All Medical Products, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
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 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021565 | Luther Safety Huber Needle SetSummary page 1…ice Class: II (two) Procode: FPA CFR Reference: 880.5440 Predicate Device #1: Luther Safety Huber Needle Set Predicate 510(k) #1: K021565 Predicate Device #2: "Evans Sub-Q" (Catalog # 4206) Predicate 510(k) #2: K020530 Device Description: The Luth-All Safet… | 2002 |
| * | K020530 | Evans Sub-Q, Model MC4206Summary page 1…440 Predicate Device #1: Luther Safety Huber Needle Set Predicate 510(k) #1: K021565 Predicate Device #2: "Evans Sub-Q" (Catalog # 4206) Predicate 510(k) #2: K020530 Device Description: The Luth-All Safety Sub-Q Needle Set is a needle and administration set with a ne… | 2002 |
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K021565.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It is manufactured with conventional medical grade, biocompatible materials. It operates as a standard safety needle with the addition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042666: Luth-All Sub-Q Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042666
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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