Grand Medical Products: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Grand Medical Products” (first 1996, latest 1996), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
| MCY | Wound Dressing Kit | 1 | 1 |
| MCZ | Suture Removal Kit | 1 | 1 |
Review panels
Most recent Grand Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963724 | GAUZE SPONGE, NON X-RAY DETECTABLE | EFQ | 1996-11-29 | 74 |
| K963723 | LACERATION TRAY | LRP | 1996-11-27 | 72 |
| K963722 | IV START KIT | LRS | 1996-11-27 | 72 |
| K963721 | SKIN SCRUB TRAY | LRO | 1996-11-27 | 72 |
| K963720 | TRACHEOSTOMY KIT | LRQ | 1996-11-27 | 72 |
| K963719 | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | MCY | 1996-11-27 | 72 |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | LRO | 1996-11-27 | 72 |
| K963714 | GRAND MEDICAL SUTURE REMOVAL KIT | MCZ | 1996-11-27 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Grand Medical Products.
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.
- Grand Work Plastic Products Co., Ltd. (19 510(k)s)
- Grand Monde Trading Co., Inc. (2 510(k)s)
- Grand Design Sdn. Bhd. (1 510(k)s)
- Grand Imperial, Inc. (1 510(k)s)
- Grand Seating King Corp. (1 510(k)s)
- Grand Traverse Technologies (1 510(k)s)
- Grand Universe Trading Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Grand Medical Products?
FDA lists 8 510(k) clearances under the applicant name “Grand Medical Products” (first 1996, latest 1996), across 7 product codes 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 Grand Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grand Medical Products is 72 days.
Which FDA product codes appear under Grand Medical Products?
The most frequent FDA product codes under this applicant name are LRO (General Surgery Tray, 2); EFQ (Gauze/Sponge, Internal, 1); LRP (Tray, Surgical, 1).
Next steps
- See all 8 Grand Medical Products clearances with predicates and recalls
- Run predicate analysis for product code LRO, Grand Medical Products'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.