Richard Wolf Medical Instruments Corp.: FDA filings under this applicant name

FDA lists 153 510(k) clearances under the applicant name “Richard Wolf Medical Instruments Corp.” (first 1977, latest 2024), plus 2 PMA decisions, across 53 product codes in 10 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 165 days, against 112 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Richard Wolf Medical Instruments Corp. took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.

Top product codes

Plus 43 more product codes.

Review panels

• Gastroenterology and Urology (47)
• General and Plastic Surgery (45)
• Obstetrics and Gynecology (30)
• Orthopedic (21)
• Ear, Nose and Throat (4)
• Neurology (3)
• General Hospital (2)
• Anesthesiology (1)
• Dental (1)
• Pathology (1)

Most recent Richard Wolf Medical Instruments Corp. 510(k) clearances

143 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

12 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2019-05-23.

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.

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.

• Richard'S Medical Equip., Inc. (48 510(k)s)
• Richard Hamer Assoc., Inc. (8 510(k)s)
• Richard F. Kronner, M.D. (3 510(k)s)
• Richard James, Inc. (2 510(k)s)
• Richard D. Spradlin (1 510(k)s)
• Richard G. Deniro (1 510(k)s)
• Richard G. Lindsay (1 510(k)s)
• Richard J. Turner Assoc. (1 510(k)s)
• Richard R. Anthony, M.D. (1 510(k)s)
• Richard Scott Elliott (1 510(k)s)
• Richard Ting (1 510(k)s)
• Richard Van Haussen America, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Richard Wolf Medical Instruments Corp.?

FDA lists 153 510(k) clearances under the applicant name “Richard Wolf Medical Instruments Corp.” (first 1977, latest 2024), plus 2 PMA decisions, across 53 product codes in 10 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 Richard Wolf Medical Instruments Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Richard Wolf Medical Instruments Corp. is 90 days. Since 2017: 165 days, versus 112 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Richard Wolf Medical Instruments Corp.?

The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 28); HRX (Arthroscope, 14); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 13).

Next steps

• See all 153 Richard Wolf Medical Instruments Corp. clearances with predicates and recalls
• Run predicate analysis for product code GCJ, Richard Wolf Medical Instruments Corp.'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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