FDA product code ILO: Pack, Hot Or Cold, Water Circulating
ILO is the FDA product code for pack, hot or cold, water circulating. It is a Class II device, regulated under 21 CFR 890.5720 and reviewed by the Physical Medicine panel. FDA has cleared 93 510(k) submissions under ILO, 1 in the last five years, from 53 different applicants. The average 510(k) review took 132 days (median 92). FDA has posted 22 recalls for ILO devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pack, Hot Or Cold, Water Circulating |
| Device class | Class II |
| Regulation | 21 CFR 890.5720 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ILO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 259 |
Compare with all 510(k) review times · Search every ILO clearance
Top ILO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 7 | 1997-11-03 |
| Breg, Inc. | 6 | 2007-03-29 |
| Seabrook Medical Systems, Inc. | 6 | 1994-02-22 |
| Gaymar Industries, Inc. | 5 | 2008-05-08 |
| Burke Neutech, Inc. | 4 | 1996-04-10 |
48 more applicants have ILO clearances. See the full list in Caduvo.
Most recent ILO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213097 | Pain Management Technologies, Inc. | Armory Motion | 2022-06-10 | 259 |
| K083008 | Elbio Co., Ltd. | COOLSKIN | 2009-06-10 | 245 |
| K073675 | Gaymar Industries, Inc. | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | 2008-05-08 | 132 |
| K072152 | Juniper Medical, Inc. | JUNIPER CLN1 DERMAL COOLING DEVICE | 2007-09-07 | 35 |
| K070402 | Breg, Inc. | MODIFICATION TO POLAR CARE 500 | 2007-03-29 | 45 |
Recalls for ILO devices
22 product recalls in 13 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code ILO?
ILO is the FDA product code for pack, hot or cold, water circulating. It is a Class II device, regulated under 21 CFR 890.5720 and reviewed by the Physical Medicine panel.
What device class is ILO?
Class II, regulation 21 CFR 890.5720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILO?
Across 93 cleared submissions the average was 132 days from receipt to decision (median 92).
Which companies have the most ILO clearances?
Hollister, Inc. (7); Breg, Inc. (6); Seabrook Medical Systems, Inc. (6); Gaymar Industries, Inc. (5); Burke Neutech, Inc. (4).
Have ILO devices been recalled?
Yes: 22 product recalls across 13 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code ILO
- Run a recall and safety report across every ILO manufacturer
- Watch product code ILO 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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