510(k) · Cleared

Recalled · Class I · 2026

Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule

K082689510(k) TraditionalCleared Mar 20, 2009186-day reviewClass II21 CFR 880.5200Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spectra Medical Devices, Inc. · NGT Saline, Vascular Access Flush

Cleared on Mar 20, 2009 as substantially equivalent to K023740 (Excelsior Medical Corp., 2003) after a 186-day review. Its family tree reaches back 1 generation to 2003. 2 of the 3 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided: Mar 20, 2009
Review: 186 days
Class: Class II
Product code: NGT
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K023740 (2003). 1 later device descends from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK023740 Syrex Pre-Filled SyringeExcelsior Medical Corp. · 2003 · Recalled
This deviceK082689 Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009
Descendant · cites it directly · 0 of its ownK103740 Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · Recalled (Class I)

Class I recalls in this family

K103740 Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML…cites it directly · 2011

Most influential descendants

Showing 1 of 1 · See all

K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023740	Syrex Pre-Filled Syringe	Excelsior Medical Corp.	2003	1
0 (this device)	K082689	Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule	Spectra Medical Devices, Inc.	2009	—
+1	K103740	Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule	Spectra Medical Devices, Inc.	2011	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	1

FIG. 1 — Lineage of K082689, 2003–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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 11.7 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K023740	Syrex Pre-Filled Syringe Summary page 2 …travascular access devices. Not to be used for any other purposes. 5. PREDICATE DEVICE a. K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride b. Substantial Equivalence Comparison…	Excelsior Medical Corp.	2003	1

Also cleared against K023740: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103740	Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule Class I	Spectra Medical Devices, Inc.	2011	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 6, 2026	Class I	Z-2873-2026	Nonconforming Material/Component	Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K103740 (Spectra Medical Devices, Inc., 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K023740.

How does its category compare?

All NGT devices

NGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NGT

1in 2025

2007high 6 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGT

142in 2023

2007high 219 (2011) · low 87 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NGT

1in 2025

2007high 7 (2010) · low 0 (2008)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · NGT

212in 2025

2007high 566 (2021) · low 5 (2012)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 device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082689

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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