Schiff & Co.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Schiff & Co.” (first 1988, latest 1999), across 13 product codes in 8 review panels. Median 510(k) review time under this name: 147 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 |
|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DZM | Needle, Dental | 1 | 1 |
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (4)
- General Hospital (3)
- Microbiology (3)
- Anesthesiology (1)
- Cardiovascular (1)
- Dental (1)
- Gastroenterology and Urology (1)
- Hematology (1)
Most recent Schiff & Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990511 | X-TIP INTRAOSSEOUS PERFORATOR | DZM | 1999-04-27 | 68 |
| K982136 | JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 | DTN | 1999-03-24 | 280 |
| K981629 | NUTRISAFE ENTERAL FEEDING TUBE | FPD | 1999-02-04 | 273 |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | FOS | 1998-10-01 | 147 |
| K974141 | PLUS REUSABLE RESUSCITATOR | BTM | 1998-05-21 | 199 |
| K954448 | VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM | FRA | 1996-10-28 | 399 |
| K955085 | HM-CAP EIA TEST (MODIFICATION) | LYR | 1996-02-09 | 106 |
| K944159 | HM-CAP EIA KIT | LYR | 1995-07-18 | 326 |
| K943521 | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE | FRA | 1995-02-14 | 209 |
| K896684 | KEMBLE LIQUID HANDLING SYSTEM DISPENSER | JQW | 1990-04-16 | 139 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Schiff & Co..
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.
- Schiff Photo Mechanics (2 510(k)s)
- Schiff Harding Waite (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Schiff & Co.?
FDA lists 15 510(k) clearances under the applicant name “Schiff & Co.” (first 1988, latest 1999), across 13 product codes in 8 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 Schiff & Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schiff & Co. is 147 days.
Which FDA product codes appear under Schiff & Co.?
The most frequent FDA product codes under this applicant name are FRA (Purifier, Air, Ultraviolet, Medical, 2); LYR (Helicobacter Pylori, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 15 Schiff & Co. clearances with predicates and recalls
- Run predicate analysis for product code FRA, Schiff & Co.'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.