510(k) · Cleared
ClearedWhisperject Autoinjector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandinavian Health Limited · KZH Introducer, Syringe Needle
Cleared on Sep 12, 2014 as substantially equivalent to K124026 (Scandinavian Health Limited, 2013) and 2 other predicates after a 108-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 12, 2014
- Review
- 108 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945660 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
- 3 generations backK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- 2 generations backK033696 Personal InjectorUnion Medico Aps · 2005
- 1 generation backK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- This deviceK141384 Whisperject AutoinjectorScandinavian Health Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| −3 | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| −2 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| −1 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| 0 (this device) | K141384 | Whisperject Autoinjector | Scandinavian Health Limited | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 KZH? 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 KZH device
- #1 K243232 GripMatescore 9.3 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K124026 | Lobster Auto-InjectorSummary page 4…Class II Product Code: KZH 5.3 Predicate Devices: Device name: Lobster Auto-injector 510(k) number: K124026 Device name: Autoject 2 510(k) number: K945660 Device name: Autoject 2… | 2013 |
| * | K945660 | Autoject 2Summary page 4…Device name: Lobster Auto-injector 510(k) number: K124026 Device name: Autoject 2 510(k) number: K945660 Device name: Autoject 2 510(k) number: K013362… | 1995 |
| * | K013362 | Autoject 2Summary page 4…K124026 Device name: Autoject 2 510(k) number: K945660 Device name: Autoject 2 510(k) number: K013362 5-1 5.4 Substantial Equivalence The WhisperJECTTM autoi… | 2001 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K124026.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KZH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KZH
Too few KZH 510(k)s in any year since 2007 to give a median.
Recalls per year · KZH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZH
16in 2025
MAUDE reports naming product code KZH, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 1 | 20 |
| 2012 | 2 | — | 0 | 20 |
| 2013 | 1 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 138 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 68 |
| 2017 | 1 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 88 |
| 2019 | 0 | — | 2 | 95 |
| 2020 | 0 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 87 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141384: Whisperject Autoinjector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141384
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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