510(k) Report

510(k) · Cleared

Cleared

Bioject Needle-Free Injection Management System

K121270510(k) TraditionalCleared Jul 19, 201284-day reviewClass II21 CFR 880.5430

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioject Medical Technologies, Inc. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Jul 19, 2012 as substantially equivalent to K960373 (Bioject, Inc., 1997) and 3 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1994.

Decided
Jul 19, 2012
Review
84 days
Class
Class II
Product code
KZE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K920631 (1994). 9 ancestors in all, the oldest K771203 (1977). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1977: 1 other ancestor2004: 1 other ancestor1994: 1 other ancestorK920631 · Bioject Jet Injection System · Bioject, Inc. · 1994K960373 · Biojector 2000 Model 1B02000 · Bioject, Inc. · 1997K081532 · Pharmajet Needle-Free Injection System · Pharmajet, Inc. · 2009K110456 · Pharmajet 0.1 ML Intradermal Needle-Free Injection System · Pharmajet, Inc. · 20111980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors K110456 · Pharmajet 0.1 ML Intradermal Needle-Free Injection System · Pharmajet, Inc. · 2011K081532 · Pharmajet Needle-Free Injection System · Pharmajet, Inc. · 2009K960373 · Biojector 2000 Model 1B02000 · Bioject, Inc. · 1997K920631 · Bioject Jet Injection System · Bioject, Inc. · 19940
  1. Root · 4 generations backK920631 Bioject Jet Injection SystemBioject, Inc. · 1994
  2. 3 generations backK960373 Biojector 2000 Model 1B02000Bioject, Inc. · 1997
  3. 2 generations backK081532 Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
  4. 1 generation backK110456 Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  5. This deviceK121270 Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K920631Bioject Jet Injection SystemBioject, Inc.1994—
−3K960373Biojector 2000 Model 1B02000Bioject, Inc.1997—
−2K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc.2009—
−1K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc.2011—
0 (this device)K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
199410
199820
200410
FIG. 1 — Lineage of K121270, 1994–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K960373Biojector 2000 Model 1B02000
Summary page 1
…21 CFR 880.5430, Product Code KZE Predicate Device(s): Biojector@ 2000 Needle-Free Injection Management System (K960373) Becton Dickinson Single Use Hypodermic and Insulin Syringe (K980580)…
Bioject, Inc.1997—
*K980580Becton Dickinson Syringes
Summary page 1
…ement System (K960373) Becton Dickinson Single Use Hypodermic and Insulin Syringe (K980580) Terumo America, Inc Disposable Hypodermic Needle (K771203) PharmaJet 0…
Bd Becton Dickinson Vacutainer Systems Preanalytic1998—
*K771203Disp. Hypodermic Needle
Summary page 1
…Dickinson Single Use Hypodermic and Insulin Syringe (K980580) Terumo America, Inc Disposable Hypodermic Needle (K771203) PharmaJet 0.1 ml Needle-free Injector Systibtn (K110456) Purpose of Submission: To add a new Indic…
Terumo America, Inc.19771
*K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection System
Summary page 1
…580) Terumo America, Inc Disposable Hypodermic Needle (K771203) PharmaJet 0.1 ml Needle-free Injector Systibtn (K110456) Purpose of Submission: To add a new Indication for Use with the Biojector@ 2000 to administer intraderma…
Pharmajet, Inc.2011—

Also cleared against K960373: 6 other devices →

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 18 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • 6 other devices also cite its predicate K960373.

How does its category compare?

All KZE devices

KZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KZE

1in 2012

2009: 42011: 22012: 1
2007high 4 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZE

220in 2009

2009: 220 days median
2007high 220 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KZE

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZE

1in 2025

2007: 542008: 52009: 82010: 92011: 72012: 62013: 42014: 102019: 12022: 12024: 12025: 1
2007high 54 (2007) · low 0 (2015)2025

MAUDE reports naming product code KZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—054
20080—05
2009422008
20100—19
20112—07
20121—06
20130—04
20140—010
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM)or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may 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.

Also cleared against K960373

6 other devices cite the same predicate.

  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
  • K090003ZetajetBioject, Inc. · 20091 recall
  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
  • K082138Airgent, Model AG7000010Perfaction, Inc. · 2009
  • K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004
  • K024018Avant Guardian 101Avant Medical Corporation · 2003

More from Bioject Medical Technologies, Inc.

3 FDA decisions under this applicant name. See the company

  • K043304Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2005
  • K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2004

Recent decisions in KZE

The KZE category page

  • K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis…Pharmajet, Inc. · 2011
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
  • K090003ZetajetBioject, Inc. · 20091 recall
  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009

https://510kreport.com/device/K121270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121270: Bioject Needle-Free Injection Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121270

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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