510(k) · Cleared
ClearedCompact Auto-Safety Injector (Casi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical House (Asi) Limited · KZH Introducer, Syringe Needle
Cleared on Mar 7, 2008 as substantially equivalent to K000482 (Owen Mumford, Ltd., 2000) after an 88-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 7, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000482 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K082587Auto-Safety Injector-2 (Asi-2)Medical House Products Limited · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000482 | Modification to Autoject Mini | Owen Mumford, Ltd. | 2000 | — |
| 0 (this device) | K073476 | Compact Auto-Safety Injector (Casi) | Medical House (Asi) Limited | 2008 | — |
| +1 | K082587 | Auto-Safety Injector-2 (Asi-2) | Medical House Products Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K000482 | Modification to Autoject MiniSummary page 1…Common Name: Auto-Injector Classification Name: Introducer, syringe needle Predicate Device: Modification to Autoject Mini K000482 Device Description: The CASI is a single-use, automatic, disposable and hidden-needl… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082587 | Auto-Safety Injector-2 (Asi-2) | 2008 | 0 |
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?
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Compact Auto Safety Injector (CASI) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA approved drug products with viscous liquid formulations, which are presented in standard 1 ml long BD Hypak® pre-filled syringes with staked needles.
The CASI is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073476: Compact Auto-Safety Injector (Casi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073476
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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