510(k) · Cleared
ClearedPharmajet Needle-Free Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmajet, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Feb 26, 2009 as substantially equivalent to K041239 (Genesis Medical Technology, Inc., 2004) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 26, 2009
- Review
- 269 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920631 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920631 Bioject Jet Injection SystemBioject, Inc. · 1994
- 1 generation backK960373 Biojector 2000 Model 1B02000Bioject, Inc. · 1997
- This deviceK081532 Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK110456 Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK121270 Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK111517 Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01…Pharmajet, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011 · cites it directly1descendant
- K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012 · 2 generations on0descendants
- K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…Pharmajet, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920631 | Bioject Jet Injection System | Bioject, Inc. | 1994 | — |
| −1 | K960373 | Biojector 2000 Model 1B02000 | Bioject, Inc. | 1997 | — |
| 0 (this device) | K081532 | Pharmajet Needle-Free Injection System | Pharmajet, Inc. | 2009 | — |
| +1 | K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection System | Pharmajet, Inc. | 2011 | — |
| +2 | K121270 | Bioject Needle-Free Injection Management System | Bioject Medical Technologies, Inc. | 2012 | — |
| +1 | K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis… | Pharmajet, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000Summary page 2…remarket Notification New Device Predicate Devices with Associated 510(k) Number Genesis Medical Technologies, Inc. K041239 PharmaJet Needle-free Injector Bioject, Inc. Biojector 2000 Needle-free K960373 Injection, Management System Description of D… | 2004 |
| * | K960373 | Biojector 2000 Model 1B02000Summary page 2…cate Devices with Associated 510(k) Number Genesis Medical Technologies, Inc. K041239 PharmaJet Needle-free Injector Bioject, Inc. Biojector 2000 Needle-free K960373 Injection, Management System Description of Device The PharmaJet, Inc. PharmaJet Needle-free Injector System (PharmaJet System)… | 1997 |
What descends from it? (3)
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110456 (Pharmajet, Inc., 2011) has gone furthest, with 1 descendant 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. 2009, this device’s year, is highlighted.
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 PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults, and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081532: Pharmajet Needle-Free Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081532
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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