510(k) · Cleared
ClearedCareo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)
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 Dec 22, 2005 as substantially equivalent to K012726 (Hou-Se Medical, Inc., 2001) and 2 other predicates after a 113-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Dec 22, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K012121 (2001). 3 ancestors in all, the oldest K012726 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK012121 Secureguard Retractable Safety SyringeSafegard Medical Products, Inc. · 2001 · Recalled
- 1 generation backK030976 Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003
- This deviceK052397 Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK060208 Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006 · cites it directly2descendants
- K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006 · 2 generations on1descendant
- K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | 2001 | 1 |
| −1 | K030976 | Careo Retractable Safety Syringe | Life-Shield Products, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K061055 | Careo Safety Syringe for U-100 Insulin | Life-Shield Products, Inc. | 2006 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K012726 | Prosafe Safety Syringe | 2001 |
| * | K012121 | Secureguard Retractable Safety SyringeSummary page 1…Hypodermic single lumen needle 3. PREDICATE DEVICE * SafePro* Safety Syringe (KG 12726) * SECUREGARD® Retractable Safety Syringe (K012121) * CAREO Retractable Safety Syringe (K030976)… | 2001 |
| * | K030976 | Careo Retractable Safety SyringeSummary page 1…PREDICATE DEVICE * SafePro* Safety Syringe (KG 12726) * SECUREGARD® Retractable Safety Syringe (K012121) * CAREO Retractable Safety Syringe (K030976) Kod 39 4. DEVICE DESCRIPT… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060208 | Careo Safety Syringe 1CC/ML, Models… | 2006 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K060208 (Life-Shield Products, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K012726.
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 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 a patient. The syringe should not be used for blood collection.
The CAREO Safety Syringe aids in the prevention of needlestick injuries. In additional, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052397: Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052397
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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