Heyer Schulte Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Heyer Schulte Corp.” (first 1976, latest 1979), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 3 | 3 |
| LCJ | Tissue Expander And Accessories | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Heyer Schulte Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792096 | 2 FR KELMAN CHAMBER MAINTAINER | FMI | 1979-11-16 | 29 |
| K790842 | SUBCUTANEOUS TISSUE EXPANDER | LCJ | 1979-08-03 | 93 |
| K780706 | LUMBAR NERVE ROOT SHIELD | — | 1978-09-07 | 135 |
| K780417 | ASEPTIC TRANSFER SET | GAZ | 1978-04-18 | 35 |
| K771224 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | LCJ | 1977-10-11 | 98 |
| K760778 | T-TUBE DRAIN, ROUND | GCY | 1976-11-03 | 30 |
| K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH | JXG | 1976-11-01 | 27 |
| K760784 | MISHLER 2 CHAMB FLUSHING VALVE,STAND | JXG | 1976-11-01 | 27 |
| K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING | JXG | 1976-08-30 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Heyer Schulte Corp..
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.
- Heyer America, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heyer Schulte Corp.?
FDA lists 9 510(k) clearances under the applicant name “Heyer Schulte Corp.” (first 1976, latest 1979), across 6 product codes in 3 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 Heyer Schulte Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heyer Schulte Corp. is 30 days.
Which FDA product codes appear under Heyer Schulte Corp.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 3); LCJ (Tissue Expander And Accessories, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 9 Heyer Schulte Corp. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Heyer Schulte Corp.'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.