FDA product code LRP: Tray, Surgical
LRP is the FDA product code for tray, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 22 510(k) submissions under LRP, from 20 different applicants. The average 510(k) review took 94 days (median 62). FDA has posted 109 recalls for LRP devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRP clearance
Top LRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cush Medical Products | 2 | 1994-06-28 |
| Apk Technology | 2 | 1991-07-29 |
| Grand Medical Products | 1 | 1996-11-27 |
| Osteotech, Inc. | 1 | 1995-05-31 |
| Associated Medical | 1 | 1994-03-30 |
15 more applicants have LRP clearances. See the full list in Caduvo.
Most recent LRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963723 | Grand Medical Products | LACERATION TRAY | 1996-11-27 | 72 |
| K951811 | Osteotech, Inc. | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | 1995-05-31 | 42 |
| K940239 | Cush Medical Products | EYE TRAY | 1994-06-28 | 160 |
| K935621 | Associated Medical | CUSTOM ENT PACKS | 1994-03-30 | 128 |
| K940646 | Cushindu | ORTHOPEDIC TRAY PRODUCT LINE | 1994-03-11 | 24 |
Recalls for LRP devices
109 product recalls in 53 recall events; 33 initiated in the last five years and 33 still open. Most recent: 2026-08-10.
| Year | Recalls |
|---|---|
| 2017 | 19 |
| 2018 | 4 |
| 2019 | 29 |
| 2020 | 2 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 14 |
| 2025 | 2 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code LRP?
LRP is the FDA product code for tray, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is LRP?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRP?
Across 22 cleared submissions the average was 94 days from receipt to decision (median 62).
Which companies have the most LRP clearances?
Cush Medical Products (2); Apk Technology (2); Grand Medical Products (1); Osteotech, Inc. (1); Associated Medical (1).
Have LRP devices been recalled?
Yes: 109 product recalls across 53 recall events; the most recent began 2026-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code LRP
- Run a recall and safety report across every LRP manufacturer
- Watch product code LRP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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