510(k) · Cleared
ClearedTasso+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tasso, Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Aug 12, 2022 as substantially equivalent to K220370 (Tianjin Huahong Technology Co., Ltd., 2022) after a 116-day review. Its family tree reaches back 4 generations to 1982. 3 later devices descend from it.
- Decided
- Aug 12, 2022
- Review
- 116 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K822209 (1982). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 3 generations backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- 2 generations backK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
- 1 generation backK220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022
- This deviceK221131 Tasso+Tasso, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK223201 TAP LancetYourbio Health, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK242680 LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked) · 2025
- Descendant · 2 generations on · 0 of its ownK234081 RedDrop ONE (One)Reddrop DX · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −3 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| −2 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| −1 | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K221131 | Tasso+ | Tasso, Inc. | 2022 | — |
| +1 | K223201 | TAP Lancet | Yourbio Health, Inc. | 2023 | — |
| +2 | K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025 | — |
| +2 | K234081 | RedDrop ONE (One) | Reddrop DX | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 FMK? 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 FMK device
- #1 K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII…score 25.0 · 3 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 |
|---|---|---|---|
| * | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) Cleared while this submission was under review Summary page 4…uct Code Blood Lancets 878.4850 FMK 7. Predicate Device Tianjin Huahong Technology Safety Lancet (K220370); Product Code: FMK 8. Device Description The Tasso+ device is a sterile, disposable blood lancet. After attachment of a… | 2022 |
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 |
|---|---|---|---|
| K223201 | TAP Lancet | 2023 | 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 40 years and passes through 5 companies; a new generation was cleared every 9.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K223201 (Yourbio Health, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K220370.
How does its category compare?
All FMK devicesFMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FMK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMK
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMK
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMK
47in 2025
MAUDE reports naming product code FMK, 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 | 0 | — | 4 | 1,206 |
| 2008 | 0 | — | 2 | 1,100 |
| 2009 | 0 | — | 1 | 882 |
| 2010 | 2 | — | 0 | 910 |
| 2011 | 0 | — | 0 | 1,493 |
| 2012 | 2 | — | 0 | 1,573 |
| 2013 | 1 | — | 0 | 1,301 |
| 2014 | 0 | — | 0 | 890 |
| 2015 | 0 | — | 0 | 781 |
| 2016 | 1 | — | 0 | 539 |
| 2017 | 1 | — | 0 | 531 |
| 2018 | 0 | — | 0 | 534 |
| 2019 | 2 | — | 0 | 399 |
| 2020 | 0 | — | 0 | 313 |
| 2021 | 1 | — | 0 | 245 |
| 2022 | 25 | 87 | 0 | 254 |
| 2023 | 10 | 95 | 0 | 282 |
| 2024 | 10 | 57 | 0 | 243 |
| 2025 | 4 | 59 | 0 | 47 |
| 2026 | 5 | 68 | 0 | — |
What is it indicated for?
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221131: Tasso+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221131
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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