510(k) Report

FDA applicant

Access Vascular, Inc.

Ballerica, MA9 decisions2018–20259 recalls

FDA records 9 decisions for Access Vascular, Inc. (Ballerica, MA) from 2018 to 2025: 9 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 9 of them its own earlier devices. 9 recalls are linked to its devices.

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 Access Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2018: 12020: 12021: 12022: 22025: 4
2018high 4 (2025) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

3in 2023

2021: 12022: 52023: 3
2018high 5 (2022) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Access Vascular, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Access Vascular, 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days6decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 171 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 9 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193015HydroPICC (PICC-142)Access Vascular, Inc. · 20203cite it
  • K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 20222cite it
  • K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc. · 20222cite it
  • K172885HydroPICCAccess Vascular, Inc. · 20181cites it
  • K203069HydroMIDAccess Vascular, Inc. · 20211cites it

What has FDA decided for it lately?

  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025
  • K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM)…Access Vascular, Inc. · 2025
  • K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter -…Access Vascular, Inc. · 2025
  • K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025
  • K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
  • K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc. · 20222 recalls
  • K203069HydroMIDAccess Vascular, Inc. · 20213 recalls
  • K193015HydroPICC (PICC-142)Access Vascular, Inc. · 20204 recalls

All 9 as Access Vascular, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K213550HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004Aug 31, 2023Class II
  • K213550HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002Aug 31, 2023Class II
  • K193015HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004Mar 3, 2023Class II
  • K203069HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days)…Dec 22, 2022Class II
  • K203069HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days)…Dec 22, 2022Class II
  • K193015HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002Dec 16, 2022Class II

Other applicant names beginning “Access”

FDA records each applicant name separately; these may or may not be the same firm.

Access Scientific, Inc. 14Access Surgical Intl., Inc. 9Access / God Loves You 4Access Point Medical, LLC 4Access Bio Incorporate 4Access Bio, Inc. 3Access Devices, Inc. 3Access Pharmaceuticals, Inc. 2Access Battery, Inc. 2Access Radiology Corp. 2Access Cardiosystems, Inc. 2Access Point Technologies Ep, Inc. 1