510(k) · Cleared
ClearedSol-Guard Insulin and Tuberculin Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sol-Millennium Medical, Inc. · MEG Syringe, Antistick
Cleared on May 22, 2014 as substantially equivalent to K061492 (Tyco Healthcare, 2006) after a 267-day review. Its family tree reaches back 2 generations to 1992. 16 later devices descend from it.
- Decided
- May 22, 2014
- Review
- 267 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922522 (1992). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922522 Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSherwood Medical Co. · 1992 · Recalled
- 1 generation backK061492 Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare · 2006
- This deviceK132681 Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · 2 generations on · 6 of its ownK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
- Descendant · 3 generations on · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · cites it directly14descendants
- K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021 · 2 generations on6descendants
- K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023 · 2 generations on2descendants
- K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd · 2024 · 3 generations on1descendant
- K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · 3 generations on1descendant
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 | K061492 | Monoject Magellan Insulin and Tuberculin Safety Syringe | Tyco Healthcare | 2006 | — |
| 0 (this device) | K132681 | Sol-Guard Insulin and Tuberculin Safety Syringe | Sol-Millennium Medical, Inc. | 2014 | — |
| +1 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +2 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| +2 | K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023 | — |
| +3 | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024 | — |
| +3 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K061492 | Monoject Magellan Insulin and Tuberculin Safety SyringeSummary page 1…dicate Device: Kendall Monoject Magellan Insulin and TB Safety Syringe Predicate 5 10(k) #:K061492 Predicate product code: MEG D. Device Description The Sol-Guard… | 2006 |
What descends from it? (16)
See all 162 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K192551 (Jiangsu Caina Medical Co.,Ltd, 2020) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K061492.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin.
The Sol-Guard TB Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.
The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin.
The Sol-Guard Insulin Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132681: Sol-Guard Insulin and Tuberculin 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/K132681
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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