510(k) · Cleared
ClearedMicronjet 600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanopass Technologies, Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 3, 2010 as substantially equivalent to K980796 (Terumo Corp., 1998) and 2 other predicates after a 148-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 3, 2010
- Review
- 148 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K941657 (1994). 12 ancestors in all, the oldest K931367 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −1 | K980796 | Terumo Allergy Syringe | Terumo Corp. | 1998 | — |
| 0 (this device) | K092746 | Micronjet 600 | Nanopass Technologies, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K980796 | Terumo Allergy SyringeSummary page 2…16 1\DC - 02UMN004O1 -2955294v2 Predicate Devices 1. Terumo Medical Corporation - Terumo Allergy Syringe (K980796) 2. BD Medical Surgical - BD PrecisionulideTm (K02 1475) 3. Becton Dickinson SafetyGlideTM Syringe (K992734) Intended Use I Indic… | 1998 |
| * | K021475 | BD Single Lumen Needle, Syringe and Blood Collection SetSummary page 2…- 02UMN004O1 -2955294v2 Predicate Devices 1. Terumo Medical Corporation - Terumo Allergy Syringe (K980796) 2. BD Medical Surgical - BD PrecisionulideTm (K02 1475) 3. Becton Dickinson SafetyGlideTM Syringe (K992734) Intended Use I Indications for Use The MicronJet 600 is intended to be used… | 2002 |
| * | K992734 | Becton Dickinson SyringeSummary page 2…ices 1. Terumo Medical Corporation - Terumo Allergy Syringe (K980796) 2. BD Medical Surgical - BD PrecisionulideTm (K02 1475) 3. Becton Dickinson SafetyGlideTM Syringe (K992734) Intended Use I Indications for Use The MicronJet 600 is intended to be used for injecting fluids into parts of the body below t… | 1999 |
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 16 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K980796.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for intradermal injections of any substance or drug approved for this delivery route.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092746: Micronjet 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092746
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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