Hogan & Hartson: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Hogan & Hartson” (first 1980, latest 1998), across 21 product codes in 10 review panels. Median 510(k) review time under this name: 94 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRL | Tester, Defibrillator | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPO | Stretcher, Wheeled | 1 | 1 |
Plus 11 more product codes.
Review panels
- Immunology (6)
- General and Plastic Surgery (4)
- General Hospital (3)
- Anesthesiology (2)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
- Orthopedic (2)
- Physical Medicine (2)
- Radiology (2)
- Obstetrics and Gynecology (1)
Most recent Hogan & Hartson 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974168 | COOPERSURGICAL INFRARED COAGULATOR | KNS | 1998-01-23 | 79 |
| K973849 | BIOABSORBABLE BANKART TACK | MAI | 1998-01-06 | 90 |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | IWE | 1997-11-20 | 90 |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | MQA | 1996-05-23 | 492 |
| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | HET | 1996-02-16 | 639 |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | MID | 1996-01-24 | 399 |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | MID | 1996-01-24 | 399 |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | MID | 1996-01-24 | 399 |
| K946186 | CHAL-2500 | IPF | 1995-08-14 | 237 |
| K941566 | COMPUSPEAK | LLZ | 1995-06-30 | 455 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hogan & Hartson.
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.
- Hogan Lovells US LLP (3 510(k)s)
- Hogan/Cologne Ent. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hogan & Hartson?
FDA lists 26 510(k) clearances under the applicant name “Hogan & Hartson” (first 1980, latest 1998), across 21 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 Hogan & Hartson?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hogan & Hartson is 94 days.
Which FDA product codes appear under Hogan & Hartson?
The most frequent FDA product codes under this applicant name are MID (System, Test, Anticardiolipin Immunological, 3); GEX (Powered Laser Surgical Instrument, 2); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 2).
Next steps
- See all 26 Hogan & Hartson clearances with predicates and recalls
- Run predicate analysis for product code MID, Hogan & Hartson'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.