FDA product code OJA: Intravenous Extension Tubing Set
OJA is the FDA product code for intravenous extension tubing set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OJA. The average 510(k) review took 21 days (median 21). FDA has posted 4 recalls for OJA devices, 4 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 | Intravenous Extension Tubing Set |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OJA clearance
Top OJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life-Tech Intl., Inc. | 1 | 1987-08-28 |
Most recent OJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873109 | Life-Tech Intl., Inc. | MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET | 1987-08-28 | 21 |
Recalls for OJA devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-14.
| Year | Recalls |
|---|---|
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OJA?
OJA is the FDA product code for intravenous extension tubing set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is OJA?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OJA?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most OJA clearances?
Life-Tech Intl., Inc. (1).
Have OJA devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OJA
- Run a recall and safety report across every OJA manufacturer
- Watch product code OJA 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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