510(k) · Cleared
ClearedCovertip Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisys Technologies, Inc. · MEG Syringe, Antistick
Cleared on May 15, 1998 as substantially equivalent to K920321 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) and 1 other predicate after a 417-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 15, 1998
- Review
- 417 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895024 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895024 Punctur-Guard (TM) Blood Collection NeedleBio-Plexus, Inc. · 1990
- This deviceK971077 Covertip Safety SyringeMedisys Technologies, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895024 | Punctur-Guard (TM) Blood Collection Needle | Bio-Plexus, Inc. | 1990 | — |
| 0 (this device) | K971077 | Covertip Safety Syringe | Medisys Technologies, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K920321 | Becton Dickinson Safety-Lok SyringeSummary page 3…ndard Syringe Safety-Lok Punctur-Guard Syringe Syringe Manufacturer Medisys Tech. Becton Dickinson | Becton Dickinson Bioplexus 510(k) # current document pre-enactment K920321 K895024 Indicated for IM yes yes yes no injection Standard piston yes yes yes no - blood syringe collection needle Safety fe… | 1992 |
| * | K895024 | Punctur-Guard (TM) Blood Collection NeedleSummary page 3…ringe Safety-Lok Punctur-Guard Syringe Syringe Manufacturer Medisys Tech. Becton Dickinson | Becton Dickinson Bioplexus 510(k) # current document pre-enactment K920321 K895024 Indicated for IM yes yes yes no injection Standard piston yes yes yes no - blood syringe collection needle Safety feature sh… | 1990 |
| * | — | Standard Syringe Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K920321.
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 CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971077: Covertip Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971077
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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