510(k) · Cleared
ClearedUltimed Ulticare Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultimed, Inc. · MEG Syringe, Antistick
Cleared on Jun 25, 2008 as substantially equivalent to K922522 (Sherwood Medical Co., 1992) after a 114-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Jun 25, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922522 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922522 Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSherwood Medical Co. · 1992 · Recalled
- This deviceK080600 Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK103011 Ulticare Safety Insulin SyringeUlti-Med Intl., Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK150758 Safelock Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK140949 Ulticare Safety Syringe with Removable NeedleUltimed Incorporated · 2015
Most influential descendants
Showing 3 of 3 · See all- K103011Ulticare Safety Insulin SyringeUlti-Med Intl., Inc. · 2011 · cites it directly1descendant
- K150758Safelock Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd. · 2015 · 2 generations on0descendants
- K140949Ulticare Safety Syringe with Removable NeedleUltimed Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922522 | Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes | Sherwood Medical Co. | 1992 | 4 |
| 0 (this device) | K080600 | Ultimed Ulticare Safety Syringe | Ultimed, Inc. | 2008 | — |
| +1 | K103011 | Ulticare Safety Insulin Syringe | Ulti-Med Intl., Inc. | 2011 | — |
| +2 | K150758 | Safelock Disposable Insulin Syringe | Jiangyin Caina Technology Co., Ltd. | 2015 | — |
| +1 | K140949 | Ulticare Safety Syringe with Removable Needle | Ultimed Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 2 | 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? (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 |
|---|---|---|---|
| * | K922522 | Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSummary page 1…substantially equivalent in intended use, function and basic composition to the currently marketed Sherwood Medical Co. Monoject Safety Syringe Icc, 3cc and 12 cc size (K922522). Device Description The UltiMed UltiCare Safety Syringe is a standard piston type syringe with permanently attached (uni-body)… | 1992 |
What descends from it? (3)
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?
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
UltiMed UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety shield aids in the prevention of needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080600: Ultimed Ulticare Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080600
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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