510(k) · Cleared
ClearedMedefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medefil, Inc. · NGT Saline, Vascular Access Flush
Cleared on Jun 24, 2002 as substantially equivalent to K993518 (Medefil, Inc., 2000) after an 88-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jun 24, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993518 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993518 Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML…Medefil, Inc. · 2000
- This deviceK020996 Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML…Medefil, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK092491 Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100…Medefil, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK032417 Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · Recalled
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 | K993518 | Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3… | Medefil, Inc. | 2000 | — |
| 0 (this device) | K020996 | Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML… | Medefil, Inc. | 2002 | — |
| +1 | K092491 | Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML… | Medefil, Inc. | 2010 | 4 |
| +1 | K032417 | Heparin Lock Flush Syringe | Am2 Pat, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K993518 | Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe…Summary page 3…listed below: Medefil, Inc. Heparin I. V. Flush Syringe (K9935 18) The Medefil’s Heparin Flush Syringe Device is similar to the legally marketed predicate device in that: a) both have the same… | 2000 |
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?
- Its one ancestor has no recall.
- Of its descendants, K092491 (Medefil, Inc., 2010) has gone furthest, with 0 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.
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?
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING
INTRAVENOUS ACCESS DEVICES (IVAD)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020996: Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020996
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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