510(k) Report

510(k) · Cleared

Cleared

Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311

K101270510(k) TraditionalCleared Feb 10, 2011280-day reviewClass II21 CFR 880.5200

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

Excelsior Medical Corp. · NGT Saline, Vascular Access Flush

Cleared on Feb 10, 2011 as substantially equivalent to K962938 (Excelsior Medical Corp., 1996) and 2 other predicates after a 280-day review. Its family tree reaches back 4 generations to 2003.

Decided
Feb 10, 2011
Review
280 days
Class
Class II
Product code
NGT
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K030467 (2003). 9 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors1996: 1 other ancestor2005: 1 other ancestor1983: 1 other ancestorK030467 · Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set · Iv Medical, Inc. · 2003K063239 · Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526 · Hospira, Inc. · 2006 · recalledK080579 · Effectiv (TM) Cap · Hospira, Inc. · 2008K083508 · Swabcap · Excelsior Medical Corp. · 20091980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K083508 · Swabcap · Excelsior Medical Corp. · 2009K080579 · Effectiv (TM) Cap · Hospira, Inc. · 2008K063239 · Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526 · Hospira, Inc. · 2006 · recalledK030467 · Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set · Iv Medical, Inc. · 20030
  1. Root · 4 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
  2. 3 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
  3. 2 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
  4. 1 generation backK083508 SwabcapExcelsior Medical Corp. · 2009
  5. This deviceK101270 Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K030467Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension SetIv Medical, Inc.2003—
−3K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…Hospira, Inc.20067
−2K080579Effectiv (TM) CapHospira, Inc.2008—
−1K083508SwabcapExcelsior Medical Corp.2009—
0 (this device)K101270Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199610
200510
200820
FIG. 1 — Lineage of K101270, 2003–2011Source: 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 11.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K962938Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)
Summary page 1
…e following devices as related to intended use, technology and design characteristics: * Excelsior Disposable Syringe w/!Normal Saline (0.9% Sodium Chloride), K962938 (Excelsior Medical Corporation) * Excelsior Saline pre-filled Syringe(s) in Sterile Field Packaging, K082837 (Excelsior…
Excelsior Medical Corp.19961
*K082837Sterile Field Saline Pre-Filled Syringe (S)
Summary page 1
…e Syringe w/!Normal Saline (0.9% Sodium Chloride), K962938 (Excelsior Medical Corporation) * Excelsior Saline pre-filled Syringe(s) in Sterile Field Packaging, K082837 (Excelsior Medical Corporation) * SwabCapt K083508 (Excelsior Medical Corporation) Description of the Device SwabFlush…
Excelsior Medical Corp.20081
*K083508Swabcap
Summary page 1
…938 (Excelsior Medical Corporation) * Excelsior Saline pre-filled Syringe(s) in Sterile Field Packaging, K082837 (Excelsior Medical Corporation) * SwabCapt K083508 (Excelsior Medical Corporation) Description of the Device SwabFlush T1l is a saline intravenous flush syringe that is combined w…
Excelsior Medical Corp.2009—

Also cleared against K962938: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 8 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • 1 other device also cites its predicate K962938.

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. 2011, 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?

The flush syringe is intended for flushing of IV catheters and IV tubing.

SwabCap® is intended for use on a swab-able luer access valve as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between the line accesses. SwabCap® will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

The SwabFlush product is provided as:

1. 10 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

2. 5 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

3. 3 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

Indications for use as stated in the FDA summary.

Also cleared against K962938

1 other device cites the same predicate.

  • K1426200.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10…Excelsior Medical Corporation · 20141 recall

More from Excelsior Medical Corp.

9 FDA decisions under this applicant name. See the company

  • K130975Swabcap and SwabflushExcelsior Medical Corp. · 20132 recalls
  • K083508SwabcapExcelsior Medical Corp. · 2009
  • K082837Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 20081 recall
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 200713 recalls
  • K053120Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 20051 recall

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/K101270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101270: Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101270

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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