510(k) · Cleared
ClearedAMSafe Pre-Filled Normal Saline Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · NGT Saline, Vascular Access Flush
Cleared on Mar 22, 2022 as substantially equivalent to K183473 (Amsino International, Inc., 2019) after a 139-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it.
- Decided
- Mar 22, 2022
- Review
- 139 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K984590 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK984590 0.9% Sodium Chloride Flush SyringeBaxter Healthcare Corp · 1999 · Recalled
- 4 generations backK111034 AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011 · Recalled
- 3 generations backK120836 0.9% Sodium Chloride Flish SyringeAm USA · 2012 · Recalled
- 2 generations backK133685 0.9% Sodium Chloride Flush SyringeAm USA · 2014 · Recalled
- 1 generation backK183473 AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
- This deviceK213522 AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK231363 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models…Hantech Medical Device Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223584 Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd. · 2023
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 |
|---|---|---|---|---|---|
| −5 | K984590 | 0.9% Sodium Chloride Flush Syringe | Baxter Healthcare Corp | 1999 | 1 |
| −4 | K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | Am USA | 2011 | 2 |
| −3 | K120836 | 0.9% Sodium Chloride Flish Syringe | Am USA | 2012 | 2 |
| −2 | K133685 | 0.9% Sodium Chloride Flush Syringe | Am USA | 2014 | 1 |
| −1 | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019 | — |
| 0 (this device) | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022 | — |
| +1 | K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003… | Hantech Medical Device Co., Ltd. | 2023 | — |
| +1 | K223584 | Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 NGT? 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 NGT device
- #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.6 · 5 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 |
|---|---|---|---|
| * | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush SyringeSummary page 4…ion: II Review Panel: General Hospital c) Identification of Legally Marketed Device(s): AMSafe® Pre-Filled Normal Saline Flush Syringe, 510(k) number K183473. d) Device Description: AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9%… | 2019 |
What descends from it? (2)
2 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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K231363 (Hantech Medical Device Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183473.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGT
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGT
1in 2025
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NGT
212in 2025
MAUDE reports naming product code NGT, 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 | — | 2 | 31 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 1 | — | 1 | 18 |
| 2010 | 2 | — | 7 | 23 |
| 2011 | 3 | 219 | 1 | 20 |
| 2012 | 4 | 106 | 1 | 5 |
| 2013 | 1 | — | 1 (1) | 25 |
| 2014 | 3 | 87 | 0 | 25 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 1 (1) | 82 |
| 2017 | 2 | — | 0 | 56 |
| 2018 | 1 | — | 0 | 270 |
| 2019 | 2 | — | 2 | 340 |
| 2020 | 2 | — | 0 | 322 |
| 2021 | 0 | — | 1 (1) | 566 |
| 2022 | 3 | 151 | 1 | 282 |
| 2023 | 6 | 142 | 3 (2) | 313 |
| 2024 | 1 | — | 0 | 332 |
| 2025 | 1 | — | 1 | 212 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The AMSafe@ Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213522: AMSafe Pre-Filled Normal Saline Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213522
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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