510(k) · Cleared
ClearedAccuSert Needle Inserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emed Technologies Corporation · KZH Introducer, Syringe Needle
Cleared on Oct 20, 2022 as substantially equivalent to K010377 (Minimed, Inc., 2001) after a 364-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 20, 2022
- Review
- 364 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010377 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010377 Mimimed Sil-Serter Infusion Set Insertion System, Model 385Minimed, Inc. · 2001
- This deviceK213429 AccuSert Needle InserterEmed Technologies Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385 | Minimed, Inc. | 2001 | — |
| 0 (this device) | K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | 2022 | — |
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
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 |
|---|---|---|---|
| * | K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385Summary page 4…Syringe Needle Classification Name: Syringe needle introducer Regulation Number: 21 CFR §880.6920 Product Code: KZH III. PREDICATE DEVICE (K010377), Sil-Serter Inserter (Product Code – KZH) IV. DEVICE DESCRIPTION The EMED AccuSert Needle Inserter is a manually oper… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K010377.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213429: AccuSert Needle Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213429
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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