Precision Medical, Inc.: FDA filings under this applicant name

FDA lists 30 510(k) clearances under the applicant name “Precision Medical, Inc.” (first 1984, latest 2018), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 139 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Precision Medical, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 216 days.

Top product codes

Plus 5 more product codes.

Review panels

• Anesthesiology (24)
• General Hospital (3)
• General and Plastic Surgery (3)

Most recent Precision Medical, Inc. 510(k) clearances

20 earlier clearances. See the full list in Caduvo.

Recalls

5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2015-10-08.

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 Precision Medical, Inc. (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via CAF)

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.

• Precision Dynamics Corp. (26 510(k)s)
• Precision Spine, Inc. (26 510(k)s)
• Precision Biologicals, Inc. (20 510(k)s)
• Precision Biologic (17 510(k)s)
• Precision Med Products, Ltd. (16 510(k)s)
• Precision Acoustics Ind., Inc. (9 510(k)s)
• Precision Cap Systems (7 510(k)s)
• Precision Vascular Systems, Inc. (7 510(k)s)
• Precision Instruments, Inc. (4 510(k)s)
• Precision Laser Products, Inc. (4 510(k)s)
• Precision Medical Instruments, Inc. (4 510(k)s)
• Precision Therapy Intl., Inc. (4 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Precision Medical, Inc.?

FDA lists 30 510(k) clearances under the applicant name “Precision Medical, Inc.” (first 1984, latest 2018), across 15 product codes in 3 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 Precision Medical, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Medical, Inc. is 139 days.

Which FDA product codes appear under Precision Medical, Inc.?

The most frequent FDA product codes under this applicant name are BTA (Pump, Portable, Aspiration (Manual Or Powered), 3); BTI (Compressor, Air, Portable, 3); CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated, 3).

Next steps

• See all 30 Precision Medical, Inc. clearances with predicates and recalls
• Run predicate analysis for product code BTA, Precision Medical, 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.

All FDA device companies · FDA product code lookup