Carefusion 303, Inc.: FDA filings under this applicant name

FDA lists 7 510(k) clearances under the applicant name “Carefusion 303, Inc.” (first 2011, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 211 days. Since 2017 the median was 170 days, against 210 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under BD (Becton, Dickinson and Company), based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Carefusion 303, Inc. took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.

Top product codes

Review panels

• General Hospital (5)
• Cardiovascular (2)

Most recent Carefusion 303, Inc. 510(k) clearances

Recalls

175 product recalls in 101 recall events; 103 initiated in the last five years. Most recent: 2026-04-30.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Carefusion 303, Inc. (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via FRN)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
• E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Carefusion 2200, Inc. (14 510(k)s)
• Carefusion Germany 234 GmbH (12 510(k)s)
• Carefusion 209, Inc. (5 510(k)s)
• Carefusion, Inc. (3 510(k)s)
• Carefusion (Bd) (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Carefusion 303, Inc.?

FDA lists 7 510(k) clearances under the applicant name “Carefusion 303, Inc.” (first 2011, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Carefusion 303, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Carefusion 303, Inc. is 211 days. Since 2017: 170 days, versus 210 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Carefusion 303, Inc.?

The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).

Next steps

• See all 7 Carefusion 303, Inc. clearances with predicates and recalls
• Run predicate analysis for product code FRN, Carefusion 303, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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