Delta Medical Industries: FDA filings under this applicant name

FDA lists 27 510(k) clearances under the applicant name “Delta Medical Industries” (first 1976, latest 1984), across 17 product codes in 4 review panels. Median 510(k) review time under this name: 36 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Top product codes

Plus 7 more product codes.

Review panels

• Cardiovascular (17)
• General Hospital (7)
• Anesthesiology (1)
• Physical Medicine (1)

Most recent Delta Medical Industries 510(k) clearances

17 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Delta Medical Industries.

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 Delta Medical Industries (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.

• Delta Medical Electronics, Inc. (4 510(k)s)
• Delta Med Spa (3 510(k)s)
• Delta International Services & Logistics S.R.L (2 510(k)s)
• Delta Enterprise Corporation (1 510(k)s)
• Delta Industries, Inc. (1 510(k)s)
• Delta Life Science, Inc. (1 510(k)s)
• Delta Marketing, Inc. (1 510(k)s)
• Delta Med Srl (1 510(k)s)
• Delta Medical Manuf, Inc. (1 510(k)s)
• Delta Surgical Instruments, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Delta Medical Industries?

FDA lists 27 510(k) clearances under the applicant name “Delta Medical Industries” (first 1976, latest 1984), across 17 product codes in 4 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 Delta Medical Industries?

The median time from FDA receipt to decision across 510(k)s cleared under the name Delta Medical Industries is 36 days.

Which FDA product codes appear under Delta Medical Industries?

The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 5); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 3); DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass, 3).

Next steps

• See all 27 Delta Medical Industries clearances with predicates and recalls
• Run predicate analysis for product code FRN, Delta Medical Industries'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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