510(k) · Cleared
ClearedCareo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
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 Mar 10, 2006 as substantially equivalent to K022063 (Formosa Medical Devices, Inc., 2002) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 10, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012121 (2001). 5 ancestors in all, the oldest K012726 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK012121 Secureguard Retractable Safety SyringeSafegard Medical Products, Inc. · 2001 · Recalled
- 2 generations backK030976 Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003
- 1 generation backK052397 Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005
- This deviceK060208 Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | 2001 | 1 |
| −2 | K030976 | Careo Retractable Safety Syringe | Life-Shield Products, Inc. | 2003 | — |
| −1 | K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) | Life-Shield Products, Inc. | 2005 | — |
| 0 (this device) | K060208 | Careo Safety Syringe 1CC/ML, Models… | Life-Shield Products, Inc. | 2006 | — |
| +1 | K061055 | Careo Safety Syringe for U-100 Insulin | Life-Shield Products, Inc. | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K022063 | Safepro Safety SyringeSummary page 1…Piston syringe I fypodermic single lumen needle 3. Predicate Device * Icc SafcPro* Safety Syringe (K022063)) * CAREO Safety Syringe (3)cc/mL. 5cc/mi> l0cc/mL) (K052397) 4. Device Iscsription The Life-Shi… | 2002 |
| * | K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Summary page 1…single lumen needle 3. Predicate Device * Icc SafcPro* Safety Syringe (K022063)) * CAREO Safety Syringe (3)cc/mL. 5cc/mi> l0cc/mL) (K052397) 4. Device Iscsription The Life-Shield Products, Inc., CAREO Safety Syringe Ilcc/mL is a sterile, single use a… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061055 | Careo Safety Syringe for U-100 Insulin | 2006 | 1 |
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 5 ancestors has a recall of any class.
- Of its descendants, K061055 (Life-Shield Products, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K022063.
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 1cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient.
The CAREO Safety Syringe 1cc/mL 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/K060208 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060208: Careo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060208
Report an extraction error
Are you the manufacturer?
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