510(k) · Cleared
Recalled · Class II · 20150.9% Sodium Chloride Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Am USA · NGT Saline, Vascular Access Flush
Cleared on Aug 13, 2014 as substantially equivalent to K120836 (Am USA, 2012) after a 254-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2014
- Review
- 254 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K984590 (1999). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK984590 0.9% Sodium Chloride Flush SyringeBaxter Healthcare Corp · 1999 · Recalled
- 2 generations backK111034 AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011 · Recalled
- 1 generation backK120836 0.9% Sodium Chloride Flish SyringeAm USA · 2012 · Recalled
- This deviceK133685 0.9% Sodium Chloride Flush SyringeAm USA · 2014
- Descendant · cites it directly · 4 of its ownK183473 AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK213522 AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK231724 Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK231363 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models…Hantech Medical Device Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK223584 Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019 · cites it directly4descendants
- K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022 · 2 generations on2descendants
- K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023 · 2 generations on0descendants
- K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd. · 2023 · 3 generations on0descendants
- K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984590 | 0.9% Sodium Chloride Flush Syringe | Baxter Healthcare Corp | 1999 | 1 |
| −2 | K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | Am USA | 2011 | 2 |
| −1 | K120836 | 0.9% Sodium Chloride Flish Syringe | Am USA | 2012 | 2 |
| 0 (this device) | K133685 | 0.9% Sodium Chloride Flush Syringe | Am USA | 2014 | — |
| +1 | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019 | — |
| +2 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022 | — |
| +2 | K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt., Ltd. | 2023 | — |
| +3 | K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003… | Hantech Medical Device Co., Ltd. | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K120836 | 0.9% Sodium Chloride Flish SyringeSummary page 5…AMUSA, Nashville, TN AMUSA 510(k) 20 mL 0.9% Sodium Chloride Flush Syn’nge 20mL Sterile 51 0(k) THE PREDICATE DEVICE DESCRIPTION: The Predicate Device, 510(k) Number: K120836 (AMUSA,) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, 5 mL, or 10 mL of 0.9% Sodium Chloride Flush Solution… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | 2019 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2015 | Class II | Z-1709-2015 | Process control | Incorrect expiration date on label |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K183473 (Amsino International, Inc., 2019) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
0.9% Sodium Chloride Flush Syringes are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133685 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133685: 0.9% Sodium Chloride Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133685
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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