510(k) · Cleared
ClearedAmsino I.V. Administration Set, AMSAFE3 I.V Administration Set, Extension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · FPA Set, Administration, Intravascular
Cleared on Mar 10, 2010 as substantially equivalent to K973107 (Amsino Intl., Inc., 1997) after a 92-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Mar 10, 2010
- Review
- 92 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973107 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973107 Amsino I.V. Administration SetAmsino Intl., Inc. · 1997
- This deviceK093773 Amsino I.V. Administration Set, AMSAFE3 I.V Administration Set…Amsino International, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK101958 Amsino I.V. Administration and Extension SetsAmsino International, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK222766 Disposable Extension SetShandong Ande Healthcare Apparatus Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973107 | Amsino I.V. Administration Set | Amsino Intl., Inc. | 1997 | — |
| 0 (this device) | K093773 | Amsino I.V. Administration Set, AMSAFE3 I.V Administration Set, Extension Sets | Amsino International, Inc. | 2010 | — |
| +1 | K101958 | Amsino I.V. Administration and Extension Sets | Amsino International, Inc. | 2010 | — |
| +2 | K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2024 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 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 |
|---|---|---|---|
| * | K973107 | Amsino I.V. Administration SetSummary page 1…SINQ International, Inc. hereby submits this Special 510(k): for AMSURE ® I V. Administration Set, a modification of our previously cleared AMSUPE®LV. ADMINISTRATIONSETt~k973107). We consider our intent to market this device as confidential commercial information and requests that it be treated as such by… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101958 | Amsino I.V. Administration and Extension Sets | 2010 | 1 |
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?
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The AMSINO® I.V. ADMINISTRATION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093773: Amsino I.V. Administration Set, AMSAFE3 I.V Administration Set, Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093773
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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