510(k) · Cleared
ClearedCareo Safety Syringe for U-100 Insulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Shield Products, Inc. · MEG Syringe, Antistick
Cleared on Jul 10, 2006 as substantially equivalent to K050134 (Formosa Medical Devices, Inc., 2005) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Jul 10, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K012121 (2001). 8 ancestors in all, the oldest K980580 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK012121 Secureguard Retractable Safety SyringeSafegard Medical Products, Inc. · 2001 · Recalled
- 3 generations backK030976 Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003
- 2 generations backK052397 Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005
- 1 generation backK060208 Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
- This deviceK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | 2001 | 1 |
| −3 | K030976 | Careo Retractable Safety Syringe | Life-Shield Products, Inc. | 2003 | — |
| −2 | K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) | Life-Shield Products, Inc. | 2005 | — |
| −1 | K060208 | Careo Safety Syringe 1CC/ML, Models… | Life-Shield Products, Inc. | 2006 | — |
| 0 (this device) | K061055 | Careo Safety Syringe for U-100 Insulin | Life-Shield Products, Inc. | 2006 | — |
| +1 | K072037 | Careo Safety Syringe for U-100 Insulin 0.5CC/ML | Life-Shield Products, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K050134 | Icc Insulin Safepro Safety SyringeSummary page 1…MEG Classification Name: Syringe, Antistick 3. Predicate Device * Icc Insulin SafePro* Safety Syringe (K050134) * CAREO Safety Syringe lcc/mL (K060208) 4. Device Description The Life-Shield Products, Inc.,… | 2005 |
| * | K060208 | Careo Safety Syringe 1CC/ML, Models…Summary page 1…Syringe, Antistick 3. Predicate Device * Icc Insulin SafePro* Safety Syringe (K050134) * CAREO Safety Syringe lcc/mL (K060208) 4. Device Description The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile,… | 2006 |
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 |
|---|---|---|---|
| K072037 | Careo Safety Syringe for U-100 Insulin 0.5CC/ML | 2007 | 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 5 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K072037 (Life-Shield Products, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K050134.
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 CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.
The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061055: Careo Safety Syringe for U-100 Insulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061055
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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