Summit World Trade Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Summit World Trade Corp.” (first 1989, latest 1991), across 1 product code in 1 review panel. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 10 | 10 |
Review panels
- Radiology (10)
Most recent Summit World Trade Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905833 | MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY | LNH | 1991-02-25 | 56 |
| K905832 | MRP -5000(1): VERSION 2.0 SOFTWARE | LNH | 1991-02-25 | 56 |
| K905835 | MRP-7000: SUPPLEMENTAL R/F COILS | LNH | 1991-02-19 | 50 |
| K905834 | MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY | LNH | 1991-02-19 | 50 |
| K903318 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30 | LNH | 1990-11-20 | 118 |
| K903203 | MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION | LNH | 1990-09-17 | 59 |
| K903204 | MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL | LNH | 1990-09-07 | 49 |
| K901980 | MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE | LNH | 1990-06-28 | 57 |
| K900919 | MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS | LNH | 1990-05-14 | 83 |
| K894016 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20 | LNH | 1989-11-22 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Summit World Trade 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Summit World Trade Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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.
- Summit Medical, Inc. (14 510(k)s)
- Summit Industries, Inc. (8 510(k)s)
- Summit Doppler Systems, Inc. (7 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Glove, Inc. (5 510(k)s)
- Summit Technology, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
- Summit Access, LLC (1 510(k)s)
- Summit Durable Medical Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit World Trade Corp.?
FDA lists 10 510(k) clearances under the applicant name “Summit World Trade Corp.” (first 1989, latest 1991), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Summit World Trade Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit World Trade Corp. is 56 days.
Which FDA product codes appear under Summit World Trade Corp.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 10).
Next steps
- See all 10 Summit World Trade Corp. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Summit World Trade 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, 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.