510(k) · Cleared
ClearedTamper Proof Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Medical Industries · FMF Syringe, Piston
Cleared on May 5, 1986 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 5, 1986
- Review
- 28 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK861276 Tamper Proof CapIntl. Medical Industries · 1986
- Descendant · cites it directly · 2 of its ownK193192 Tamper Evident CapInternational Medical Industries, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK210818 TrueCare Biomedix Tamper Evident CapUs Infusion Inc. D/B/A Truecare Biomedix-USA · 2021
- Descendant · 3 generations on · 0 of its ownK252518 DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate · 2025
- Descendant · cites it directly · 0 of its ownK231095 Tamper Evident CapInternational Medical Industries, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK182545 Tamper Evident Cap with Male Luer LockInternational Medical Industries, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193192Tamper Evident CapInternational Medical Industries, Inc. · 2020 · cites it directly2descendants
- K210818TrueCare Biomedix Tamper Evident CapUs Infusion Inc. D/B/A Truecare Biomedix-USA · 2021 · 2 generations on1descendant
- K252518DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate · 2025 · 3 generations on0descendants
- K231095Tamper Evident CapInternational Medical Industries, Inc. · 2024 · cites it directly0descendants
- K182545Tamper Evident Cap with Male Luer LockInternational Medical Industries, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861276 | Tamper Proof Cap | Intl. Medical Industries | 1986 | — |
| +1 | K193192 | Tamper Evident Cap | International Medical Industries, Inc. | 2020 | — |
| +2 | K210818 | TrueCare Biomedix Tamper Evident Cap | Us Infusion Inc. D/B/A Truecare Biomedix-USA | 2021 | — |
| +3 | K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025 | — |
| +1 | K231095 | Tamper Evident Cap | International Medical Industries, Inc. | 2024 | — |
| +1 | K182545 | Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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?
- Of its descendants, K193192 (International Medical Industries, Inc., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K861276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K861276: Tamper Proof Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861276
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026