FDA product code LRS: I.V. Start Kit
LRS is the FDA product code for i.v. start kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 30 510(k) submissions under LRS, from 29 different applicants. The average 510(k) review took 142 days (median 70). FDA has posted 165 recalls for LRS devices, 41 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 | I.V. Start Kit |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRS clearance
Top LRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Customed, Inc. | 2 | 1993-08-27 |
| Amsino International, Inc. | 1 | 2005-05-02 |
| Nirvi Intl. USA | 1 | 2001-11-20 |
| Grand Medical Products | 1 | 1996-11-27 |
| Emergency Medical Supply, Inc. | 1 | 1995-05-16 |
24 more applicants have LRS clearances. See the full list in Caduvo.
Most recent LRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050654 | Amsino International, Inc. | AMSINO I.V. START KIT | 2005-05-02 | 49 |
| K001879 | Nirvi Intl. USA | INFUSION IV SET | 2001-11-20 | 518 |
| K963722 | Grand Medical Products | IV START KIT | 1996-11-27 | 72 |
| K951167 | Emergency Medical Supply, Inc. | EMS I.V. START KIT | 1995-05-16 | 63 |
| K950184 | B. Braun of America, Inc. | B. BRAUN IV START KITS | 1995-03-15 | 57 |
Recalls for LRS devices
165 product recalls in 45 recall events; 41 initiated in the last five years and 36 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 8 |
| 2022 | 14 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 | 13 |
Frequently asked questions
What is FDA product code LRS?
LRS is the FDA product code for i.v. start kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General and Plastic Surgery panel.
What device class is LRS?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRS?
Across 30 cleared submissions the average was 142 days from receipt to decision (median 70).
Which companies have the most LRS clearances?
Customed, Inc. (2); Amsino International, Inc. (1); Nirvi Intl. USA (1); Grand Medical Products (1); Emergency Medical Supply, Inc. (1).
Have LRS devices been recalled?
Yes: 165 product recalls across 45 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LRS
- Run a recall and safety report across every LRS manufacturer
- Watch product code LRS 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times