510(k) · Cleared
ClearedGenesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Medical Technology, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Nov 8, 2004 after a 181-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 181 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK041239 Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector…Genesis Medical Technology, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK081532 Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK110456 Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK121270 Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK111517 Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01…Pharmajet, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009 · cites it directly3descendants
- K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011 · 2 generations on1descendant
- K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012 · 3 generations on0descendants
- K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…Pharmajet, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000 | Genesis Medical Technology, Inc. | 2004 | — |
| +1 | K081532 | Pharmajet Needle-Free Injection System | Pharmajet, Inc. | 2009 | — |
| +2 | K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection System | Pharmajet, Inc. | 2011 | — |
| +3 | K121270 | Bioject Needle-Free Injection Management System | Bioject Medical Technologies, Inc. | 2012 | — |
| +2 | K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis… | Pharmajet, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 KZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081532 | Pharmajet Needle-Free Injection System | 2009 | 3 |
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?
- Of its descendants, K081532 (Pharmajet, Inc., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KZE devicesKZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZE
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KZE
220in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KZE
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZE
1in 2025
MAUDE reports naming product code KZE, 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 | 0 | — | 0 | 54 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 4 | 220 | 0 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GMTI PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041239: Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041239
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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