510(k) · Cleared
ClearedSmartjet Grafting Liquid Applicator, Models SK/S & LK/2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvest Technologies, Corp. · FMF Syringe, Piston
Cleared on Apr 5, 2002 as substantially equivalent to K011032 (Harvest Technologies, Corp., 2001) after a 71-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011032 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011032 Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S…Harvest Technologies, Corp. · 2001
- This deviceK020252 Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Harvest Technologies, Corp. · 2002
- Descendant · cites it directly · 0 of its ownK091722 Coaxial Applicator SystemBiomet, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK041830 Magellan Ratio Dispenser KitMedtronic Perfusion Systems · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone… | Harvest Technologies, Corp. | 2001 | — |
| 0 (this device) | K020252 | Smartjet Grafting Liquid Applicator, Models SK/S & LK/2 | Harvest Technologies, Corp. | 2002 | — |
| +1 | K091722 | Coaxial Applicator System | Biomet, Inc. | 2010 | — |
| +1 | K041830 | Magellan Ratio Dispenser Kit | Medtronic Perfusion Systems | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft…Summary page 1…s for use statement, The SmartJet Grafting Liquid Applicator is substantially equivalent to the Harvest SmartJet Bone Grafting Liquid Applicator cleared by FDA in 510(k)011032 The Harvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The devi… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The SmartJet Grafting Liquid Applicator is intended for the application of fluids, as deemed necessary by the surgeon’s determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020252: Smartjet Grafting Liquid Applicator, Models SK/S & LK/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020252
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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