Hobbs Medical, Inc.: FDA clearances and approvals
Hobbs Medical, Inc. has 21 FDA 510(k) clearances (first 1983, latest 2024), across 13 product codes in 4 review panels. Median 510(k) review time: 90 days. openFDA lists 74 product recalls by a recalling firm named Hobbs Medical, Inc.
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 | 1 | 473 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 88 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hobbs Medical, Inc.'s cleared 510(k)s took a median 280 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| OCX | Endoscopic Irrigation/Suction System | 3 | 3 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 3 | 3 |
| FDX | Endoscopic Cytology Brush | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 1 | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (18)
- Ear, Nose and Throat (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Hobbs Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | OCX | 2024-09-24 | 88 |
| K182927 | Pulmonary Cytology Brush | BTG | 2020-02-07 | 473 |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | KNS | 2010-08-02 | 306 |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | OCX | 2003-06-09 | 90 |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | FEB | 1993-10-28 | 111 |
| K922396 | FUJINON FORCEPS -- MODIFICATION | FCL | 1992-12-10 | 205 |
| K921026 | PRESSURE GAUGE | KNT | 1992-04-24 | 52 |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | EYB | 1991-11-19 | 49 |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | FDX | 1989-08-28 | 103 |
| K872509 | LINDEN STONE EXTRACTION BALLOON | FGE | 1987-09-22 | 90 |
11 earlier clearances. See the full list in Caduvo.
Recalls
74 product recalls in 6 recall events; 72 initiated in the last five years. Most recent: 2024-10-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hobbs Medical, Inc. have?
Hobbs Medical, Inc. has 21 FDA 510(k) clearances (first 1983, latest 2024), across 13 product codes in 4 review panels.
How long does FDA take to clear Hobbs Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hobbs Medical, Inc.'s cleared 510(k)s is 90 days.
What devices does Hobbs Medical, Inc. make?
Its most frequent FDA product codes are FGE (Stents, Drains And Dilators For The Biliary Ducts, 3); OCX (Endoscopic Irrigation/Suction System, 3); OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 3).
Has Hobbs Medical, Inc. had device recalls?
openFDA lists 74 product recalls in 6 recall events by a recalling firm whose name matches Hobbs Medical, Inc; the most recent began 2024-10-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 21 Hobbs Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Hobbs Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.