510(k) Report

FDA applicant

Intera Oncology, Inc.

Wellesley, MA4 decisions1982–202215 recalls

FDA records 4 decisions for Intera Oncology, Inc. (Wellesley, MA) from 1982 to 2022: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes PTI (Non-Coring (Huber) Needle) and LKK (Pump, Infusion, Implanted, Programmable). Its devices cite 1 predicate, 0 of them its own earlier devices. 15 recalls are linked to its devices, 11 Class I.

FDA’s records also spell it “Intera Oncology”.

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 Intera Oncology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 10, 10 Class I2015: 32022: 1, 1 Class I2026 (partial year): 1
2007high 10 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Intera Oncology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intera Oncology, 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?

  • PTINon-Coring (Huber) Needle2decisions
  • LKKPump, Infusion, Implanted, Programmable2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K213823Intera Refill KitIntera Oncology, Inc. · 2022
  • K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc. · 2021
  • P890055Medstream Programmable Infusion Pump SystemIntera Oncology · 199611 Class I recalls
  • P800036Infusaid Implantable Infusion Pump Model-100,200,4Intera Oncology · 1982

All 2 as Intera Oncology, Inc. →All 2 as Intera Oncology →

What has been recalled?

15 recalls linked to its devices; the latest:

  • P890055Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug…May 11, 2026Class II
  • P890055INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion…Jul 10, 2022Class I
  • P890055MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream…Nov 10, 2015Class II
  • P890055MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream…Nov 10, 2015Class II
  • P890055CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000…Mar 5, 2015Class II
  • P890055MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream…Aug 13, 2013Class I

Other applicant names beginning “Intera”

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

Intera Corp. 6