FDA product code LRO: General Surgery Tray
LRO is the FDA product code for general surgery tray. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel. FDA has cleared 110 510(k) submissions under LRO, 1 in the last five years, from 71 different applicants. The average 510(k) review took 142 days (median 78). FDA has posted 1,070 recalls for LRO devices, 453 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Classification
| Field | Value |
|---|---|
| Device name | General Surgery Tray |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LRO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 136 |
| 2022 | 1 | 207 |
Compare with all 510(k) review times · Search every LRO clearance
Top LRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Customed, Inc. | 6 | 1996-11-25 |
| Carapace, Inc. | 6 | 1994-02-07 |
| Medline Industries, Inc. | 5 | 2022-05-24 |
| Cush Medical Products | 5 | 1994-03-03 |
| Associated Medical Products Co. | 3 | 1997-03-19 |
66 more applicants have LRO clearances. See the full list in Caduvo.
Most recent LRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213481 | Medline Industries, Inc. | Medline General Surgery Tray | 2022-05-24 | 207 |
| K212258 | Medline Industries, Inc. | Medline Cardiovascular Procedure Kit | 2021-12-03 | 136 |
| K041080 | D.I.R.R.A. S.R.L. | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | 2004-11-30 | 218 |
| K030721 | Ballard Medical Products | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | 2003-03-31 | 24 |
| K023276 | Amsino International, Inc. | AMSINO TRACHEOSTOMY CARE TRAY | 2002-12-09 | 69 |
Recalls for LRO devices
1,070 product recalls in 247 recall events; 453 initiated in the last five years and 443 still open. Most recent: 2026-08-18.
| Year | Recalls |
|---|---|
| 2017 | 168 |
| 2018 | 32 |
| 2019 | 6 |
| 2020 | 22 |
| 2021 | 16 |
| 2022 | 200 |
| 2023 | 37 |
| 2024 | 78 |
| 2025 | 62 |
| 2026 | 74 |
Frequently asked questions
What is FDA product code LRO?
LRO is the FDA product code for general surgery tray. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel.
What device class is LRO?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRO?
Across 110 cleared submissions the average was 142 days from receipt to decision (median 78).
Which companies have the most LRO clearances?
Customed, Inc. (6); Carapace, Inc. (6); Medline Industries, Inc. (5); Cush Medical Products (5); Associated Medical Products Co. (3).
Have LRO devices been recalled?
Yes: 1,070 product recalls across 247 recall events; the most recent began 2026-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LRO
- Run a recall and safety report across every LRO manufacturer
- Watch product code LRO 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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