FDA product code MLS: Labor And Delivery Kit
MLS is the FDA product code for labor and delivery kit. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under MLS, from 5 different applicants. The average 510(k) review took 193 days (median 162). FDA has posted 46 recalls for MLS devices, 40 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 | Labor And Delivery Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MLS clearance
Top MLS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cush Medical Products | 2 | 1994-08-18 |
| Devon Industries, Inc. | 1 | 1996-07-03 |
| Custom Pack Reliability | 1 | 1996-05-23 |
| Associated Medical Products Co. | 1 | 1994-04-19 |
| Carapace, Inc. | 1 | 1994-03-23 |
Most recent MLS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961993 | Devon Industries, Inc. | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | 1996-07-03 | 43 |
| K960243 | Custom Pack Reliability | CPR C-SECTION DELIVERY PACK | 1996-05-23 | 128 |
| K940518 | Cush Medical Products | C-SECTION TRAY | 1994-08-18 | 195 |
| K932216 | Associated Medical Products Co. | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | 1994-04-19 | 347 |
| K936120 | Cush Medical Products | LABOR AND DELIVERY TRAY | 1994-03-30 | 97 |
Recalls for MLS devices
46 product recalls in 39 recall events; 40 initiated in the last five years and 38 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 13 |
| 2025 | 9 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code MLS?
MLS is the FDA product code for labor and delivery kit. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is MLS?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MLS?
Across 6 cleared submissions the average was 193 days from receipt to decision (median 162).
Which companies have the most MLS clearances?
Cush Medical Products (2); Devon Industries, Inc. (1); Custom Pack Reliability (1); Associated Medical Products Co. (1); Carapace, Inc. (1).
Have MLS devices been recalled?
Yes: 46 product recalls across 39 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MLS
- Run a recall and safety report across every MLS manufacturer
- Watch product code MLS 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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