510(k) · Cleared
ClearedOtter Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otter (China) Technology Co., Ltd. · MEG Syringe, Antistick
Cleared on Apr 22, 2004 after a 51-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 22, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK040545 Otter Safety SyringeOtter (China) Technology Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK142435 3S Safety Syringe with/without NeedleSincere Medical Device Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK152606 Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK212518 Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK050116 Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005
Most influential descendants
Showing 4 of 4 · See all- K1424353S Safety Syringe with/without NeedleSincere Medical Device Co., Ltd. · 2015 · cites it directly2descendants
- K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2016 · 2 generations on1descendant
- K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2022 · 3 generations on0descendants
- K050116Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040545 | Otter Safety Syringe | Otter (China) Technology Co., Ltd. | 2004 | — |
| +1 | K142435 | 3S Safety Syringe with/without Needle | Sincere Medical Device Co., Ltd. | 2015 | — |
| +2 | K152606 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2016 | — |
| +3 | K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022 | — |
| +1 | K050116 | Uniqsafe Rotatable, Retractable Safety Syringes | Uniqsafe Biomeditech Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Duopro Safety Syringe Named without a submission number | |
| * | — | SecureGard Retractable Safety Syringe Named without a submission number | |
| * | — | SEZ Safety Syringe Named without a submission number | |
| * | — | Nipro hypodermic needle Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K142435 (Sincere Medical Device Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040545 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040545: Otter Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040545
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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