510(k) · Cleared
ClearedTrueCare Biomedix Tamper Evident Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Infusion Inc. D/B/A Truecare Biomedix-USA · FMF Syringe, Piston
Cleared on Sep 15, 2021 as substantially equivalent to K193192 (International Medical Industries, Inc., 2020) after a 181-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Sep 15, 2021
- Review
- 181 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861276 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK861276 Tamper Proof CapIntl. Medical Industries · 1986
- 1 generation backK193192 Tamper Evident CapInternational Medical Industries, Inc. · 2020
- This deviceK210818 TrueCare Biomedix Tamper Evident CapUs Infusion Inc. D/B/A Truecare Biomedix-USA · 2021
- Descendant · cites it directly · 0 of its ownK252518 DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate · 2025
Most influential descendants
Showing 1 of 1 · See all- K252518DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861276 | Tamper Proof Cap | Intl. Medical Industries | 1986 | — |
| −1 | K193192 | Tamper Evident Cap | International Medical Industries, Inc. | 2020 | — |
| 0 (this device) | K210818 | TrueCare Biomedix Tamper Evident Cap | Us Infusion Inc. D/B/A Truecare Biomedix-USA | 2021 | — |
| +1 | K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K193192 | Tamper Evident CapSummary page 4…Number: 21 CFR 880.5860 Product Code: FMF Device Class: Class ll Predicate Device: K193192 – International Medical Industries Prep-Lock Tamper Evident Cap V. Produ… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252518 | DuoprossTM Smart Cap (Type I) | 2025 | 0 |
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 35 years and passes through 3 companies; a new generation was cleared every 33.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252518 (Duopross Meditech Corporate, 2025) has gone furthest, with 0 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. 2021, this device’s year, is highlighted.
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) | — |
What is it indicated for?
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210818: TrueCare Biomedix Tamper Evident Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210818
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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