510(k) · Cleared
ClearedUlticare Safety Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulti-Med Intl., Inc. · MEG Syringe, Antistick
Cleared on Feb 2, 2011 as substantially equivalent to K080600 (Ultimed, Inc., 2008) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Feb 2, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922522 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922522 Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSherwood Medical Co. · 1992 · Recalled
- 1 generation backK080600 Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008
- This deviceK103011 Ulticare Safety Insulin SyringeUlti-Med Intl., Inc. · 2011
- Descendant · cites it directly · 0 of its ownK150758 Safelock Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150758Safelock Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922522 | Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes | Sherwood Medical Co. | 1992 | 4 |
| −1 | K080600 | Ultimed Ulticare Safety Syringe | Ultimed, Inc. | 2008 | — |
| 0 (this device) | K103011 | Ulticare Safety Insulin Syringe | Ulti-Med Intl., Inc. | 2011 | — |
| +1 | K150758 | Safelock Disposable Insulin Syringe | Jiangyin Caina Technology Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K080600 | Ultimed Ulticare Safety SyringeSummary page 1…FMF Class 11 Hypodermic Single Lumen Needle § 880.5570 EMI Class 11 Predicate Device(s): K080600: UltiMed UltiCareM Safety Syringe K922522: Sherwood (Tyco) Monoject® Safety Syringe (Model… | 2008 |
| * | K922522 | Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSummary page 1…le Lumen Needle § 880.5570 EMI Class 11 Predicate Device(s): K080600: UltiMed UltiCareM Safety Syringe K922522: Sherwood (Tyco) Monoject® Safety Syringe (Model Monoject Insulin Safety Syringe) Device Des… | 1992 |
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 |
|---|---|---|---|
| K150758 | Safelock Disposable Insulin Syringe | 2015 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K150758 (Jiangyin Caina Technology Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080600.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103011: Ulticare Safety Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103011
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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