FDA product code ITG: Bandage, Cast
ITG is the FDA product code for bandage, cast. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. FDA has cleared 37 510(k) submissions under ITG, from 24 different applicants. The average 510(k) review took 40 days (median 35). FDA has posted 3 recalls for ITG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bandage, Cast |
| Device class | Class I |
| Regulation | 21 CFR 890.3025 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ITG clearance
Top ITG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hexcel Medical | 4 | 1984-03-23 |
| Secol Co. | 3 | 1981-02-04 |
| Johnson & Johnson Professionals, Inc. | 3 | 1979-05-18 |
| Solar Laboratories, Inc. | 3 | 1977-01-26 |
| Smith & Nephew, Inc. | 2 | 1983-11-14 |
19 more applicants have ITG clearances. See the full list in Caduvo.
Most recent ITG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873111 | The Kendal Co. | CONFORMA(TM) PLASTER BANDAGES | 1987-10-09 | 60 |
| K862115 | Deknatel, Inc. | DEKNA BAND KIT | 1986-08-19 | 77 |
| K842573 | The Poly Group, Inc. | T.P.G. CAST TAPE | 1984-08-10 | 38 |
| K840416 | Hexcel Medical | HEXCELITE | 1984-03-23 | 52 |
| K833732 | American Medical Disposable, Inc. | NON WETTING UNDERCAST PADDING | 1983-12-12 | 48 |
Recalls for ITG devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-01-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code ITG?
ITG is the FDA product code for bandage, cast. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is ITG?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITG?
Across 37 cleared submissions the average was 40 days from receipt to decision (median 35).
Which companies have the most ITG clearances?
Hexcel Medical (4); Secol Co. (3); Johnson & Johnson Professionals, Inc. (3); Solar Laboratories, Inc. (3); Smith & Nephew, Inc. (2).
Have ITG devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2026-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code ITG
- Run a recall and safety report across every ITG manufacturer
- Watch product code ITG 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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