Intera Oncology

Newton, MA, US

INTERA ONCOLOGY appears in FDA device records in Newton, MA. FDA records list 2 510(k) clearances between 2021-10-14 and 2022-03-16, 119 PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 119
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Intera Oncology between 2021 and 2022. The busiest year on record is 2021, with 1. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Intera Oncology, by decision year
Year	Clearances
2021	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K213823	Intera Refill Kit	PTI	Substantially Equivalent	2022-03-16
K211121	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit	PTI	Substantially Equivalent	2021-10-14

Registered establishments

FDA registered establishments for Intera Oncology, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015537318	3015537318	INTERA ONCOLOGY	180 Wells Avenue, Newton, MA 02459 US	2026	LKK PTI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1522-2022	INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.	Higher than expected flow rate.	Class I	2022-07-10	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain