A.Stein - Regulatory Affairs Consulting: FDA clearances and approvals
A.Stein - Regulatory Affairs Consulting has 5 FDA 510(k) clearances (first 1997, latest 1999), across 5 product codes in 5 review panels. Median 510(k) review time: 155 days.
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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KLZ | Tube, Shunt, Endolymphatic With Valve | 1 | 1 |
| LKX | Device, Thermal, Hemorrhoids | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent A.Stein - Regulatory Affairs Consulting 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972383 | EASY-JET DEVICE | KLZ | 1999-11-23 | 880 |
| K973592 | WALKCARE P200 SYSTEM | JOW | 1999-05-20 | 605 |
| K982754 | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) | FWF | 1999-01-08 | 155 |
| K973590 | HEMORRELIEF DEVICE | LKX | 1998-02-05 | 136 |
| K973148 | MACOM | LLZ | 1997-11-20 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named A.Stein - Regulatory Affairs Consulting.
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 A.Stein - Regulatory Affairs Consulting have?
A.Stein - Regulatory Affairs Consulting has 5 FDA 510(k) clearances (first 1997, latest 1999), across 5 product codes in 5 review panels.
How long does FDA take to clear A.Stein - Regulatory Affairs Consulting's 510(k)s?
The median time from FDA receipt to decision across A.Stein - Regulatory Affairs Consulting's cleared 510(k)s is 155 days.
What devices does A.Stein - Regulatory Affairs Consulting make?
Its most frequent FDA product codes are FWF (Camera, Television, Endoscopic, Without Audio, 1); JOW (Sleeve, Limb, Compressible, 1); KLZ (Tube, Shunt, Endolymphatic With Valve, 1).
Has A.Stein - Regulatory Affairs Consulting had device recalls?
openFDA lists no recalls under a recalling firm name matching A.Stein - Regulatory Affairs Consulting. Related entities may recall under other names.
Next steps
- See all 5 A.Stein - Regulatory Affairs Consulting clearances with predicates and recalls
- Run predicate analysis for product code FWF, A.Stein - Regulatory Affairs Consulting'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.