510(k) Report

FDA applicant

Nurse Assist, Inc.

Haltom City, TX4 decisions2008–20204 recalls

FDA records 4 decisions for Nurse Assist, Inc. (Haltom City, TX) from 2008 to 2020: 4 510(k) clearances. Most are in product codes NGT (Saline, Vascular Access Flush) and FRO (Dressing, Wound, Drug). Its devices cite 7 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.

FDA’s records also spell it “Nurse Assist, LLC”.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Nurse Assist, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12012: 12015: 12020: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2023

2016: 1, 1 Class I2023: 3, 3 Class I
2008high 3 (2023) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Nurse Assist, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nurse Assist, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NGTSaline, Vascular Access Flush2decisions
  • FRODressing, Wound, Drug1decision
  • KMJLubricant, Patient1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 20086cite it
  • K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V.…Nurse Assist, LLC · 20201cites it

What has FDA decided for it lately?

  • K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V.…Nurse Assist, LLC · 20202 Class I recalls
  • K150143Normal Saline FlushNurse Assist, Inc. · 20151 Class I recall
  • K121390Lube Jelly SuringeNurse Assist, Inc. · 2012
  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 20082 Class I recalls

All 3 as Nurse Assist, Inc. →The one decision as Nurse Assist, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K2012860.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240Nov 6, 2023Class I
  • K2012860.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL…Nov 6, 2023Class I
  • K083042Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE…Nov 6, 2023Class I
  • K150143Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and…Oct 4, 2016Class I