American Heyer Schulte: FDA clearances and approvals
American Heyer Schulte has 13 FDA 510(k) clearances (first 1980, latest 1984), across 8 product codes in 4 review panels. Median 510(k) review time: 71 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 4 | 4 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| GDW | Staple, Implantable | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 | 1 |
| JCY | Catheter, Infusion | 1 | 1 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 1 | 1 |
Review panels
- General and Plastic Surgery (7)
- Neurology (4)
- General Hospital (1)
- Radiology (1)
Most recent American Heyer Schulte 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840172 | VENTRAL WALL DEFECT REDUCT SILO | FTL | 1984-06-27 | 162 |
| K834593 | ONE-PIECE SHUNT | JXG | 1984-04-03 | 96 |
| K833502 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | LCJ | 1984-02-03 | 121 |
| K833698 | AMER. V. MUELLER SURG. STAPLES ILA | GDW | 1984-01-25 | 71 |
| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | GDW | 1983-12-29 | 72 |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | IWJ | 1983-09-29 | 48 |
| K823790 | VENTRICULAR ACCESS SYSTEM | LKG | 1983-04-28 | 133 |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | JCY | 1983-04-12 | 270 |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | GCY | 1982-08-16 | 35 |
| K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | JXG | 1982-02-18 | 20 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Heyer Schulte.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of American Heyer Schulte's product codes (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
Frequently asked questions
How many FDA 510(k) clearances does American Heyer Schulte have?
American Heyer Schulte has 13 FDA 510(k) clearances (first 1980, latest 1984), across 8 product codes in 4 review panels.
How long does FDA take to clear American Heyer Schulte's 510(k)s?
The median time from FDA receipt to decision across American Heyer Schulte's cleared 510(k)s is 71 days.
What devices does American Heyer Schulte make?
Its most frequent FDA product codes are JXG (Shunt, Central Nervous System And Components, 4); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 2); GDW (Staple, Implantable, 2).
Has American Heyer Schulte had device recalls?
openFDA lists no recalls under a recalling firm name matching American Heyer Schulte. Related entities may recall under other names.
Next steps
- See all 13 American Heyer Schulte clearances with predicates and recalls
- Run predicate analysis for product code JXG, American Heyer Schulte'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.