510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Medefil's Normal Saline I.V. Flush Syringe

K091583510(k) SpecialCleared Jan 28, 2010240-day reviewClass II21 CFR 880.5200Recalls 1

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

Medefil, Inc. · NGT Saline, Vascular Access Flush

Cleared on Jan 28, 2010 as substantially equivalent to K020999 (Medefil, Inc., 2002) after a 240-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.

Decided
Jan 28, 2010
Review
240 days
Class
Class II
Product code
NGT
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K993515 (2000). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant clearedK993515 · Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6 ML Syringe L · Medefil, Inc. · 2000K020999 · Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K020999 · Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 2002K993515 · Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6 ML Syringe L · Medefil, Inc. · 20000
  1. Root · 2 generations backK993515 Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML…Medefil, Inc. · 2000
  2. 1 generation backK020999 Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML…Medefil, Inc. · 2002
  3. This deviceK091583 Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc. · 2010
  4. Descendant · cites it directly · 0 of its ownK121262 Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K993515Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3…Medefil, Inc.2000—
−1K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6…Medefil, Inc.2002—
0 (this device)K091583Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc.2010—
+1K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K091583, 2000–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…
Summary page 2
…Medefil, Inc. Normal Saline I. V. Flush Syringe (K020999) The proposed modification involves change in the polypropylene and sterilization process.…
Medefil, Inc.2002—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2022Class IIZ-1619-2022Environmental controlFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 7.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K121262 (Medefil, Inc., 2012) has gone furthest, with 0 descendants of its own.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · NGT

1in 2025

2008: 12009: 12010: 22011: 32012: 42013: 12014: 32015: 12016: 12017: 22018: 12019: 22020: 22022: 32023: 62024: 12025: 1
2007high 6 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGT

142in 2023

2011: 219 days median2012: 106 days median2014: 87 days median2022: 151 days median2023: 142 days median
2007high 219 (2011) · low 87 (2014)2026

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

Recalls per year · NGT

1in 2025

2007: 22009: 12010: 72011: 12012: 12013: 1, 1 Class I2016: 1, 1 Class I2019: 22021: 1, 1 Class I2022: 12023: 3, 2 Class I2025: 12026 (partial year): 1, 1 Class I
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

2007: 312008: 642009: 182010: 232011: 202012: 52013: 252014: 252015: 142016: 822017: 562018: 2702019: 3402020: 3222021: 5662022: 2822023: 3132024: 3322025: 212
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—231
20081—064
20091—118
20102—723
20113219120
2012410615
20131—1 (1)25
2014387025
20151—014
20161—1 (1)82
20172—056
20181—0270
20192—2340
20202—0322
20210—1 (1)566
202231511282
202361423 (2)313
20241—0332
20251—1212
20260—1 (1)—

What is it indicated for?

FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

Indications for use as stated in the FDA summary.

More from Medefil, Inc.

7 FDA decisions under this applicant name. See the company

  • K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012
  • K092491Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill SizesMedefil, Inc. · 20104 recalls
  • K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML…Medefil, Inc. · 2002
  • K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6…Medefil, Inc. · 2002
  • K993518Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 2000

Recent decisions in NGT

The NGT category page

  • K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company · 2025
  • K233623Praxiject™ SP 0.9% NaClMedxl, Inc. · 2024
  • K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023
  • K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd. · 2023
  • K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2023

https://510kreport.com/device/K091583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091583: Medefil's Normal Saline I.V. Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091583

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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