Anago Warm Pack
FDA 510(k) K926589 · Anago, Inc.
510(k) numberK926589
Submission
- Device name
- Anago Warm Pack
- Applicant
- Anago, Inc.
Fort Worth, TX, US - Received
- December 7, 1992
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
Other 510(k)s with product code IMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming MattressIMD · Traditional | International Biomedical | 10/06/2022SE |
| K163295 | Infant Transport Mattress Warmer with DiscIMD · Traditional | Rapid Aid Corp. | 07/24/2017SE |
| K112547 | Neo NestIMD · Traditional | Denovo Proucts, LLC | 03/06/2012SE |
| K082087 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/11/2008SE |
| K071710 | Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)IMD · Traditional | Johnson & Johnson Consumer Products, Inc. | 08/14/2007SE |
| K021843 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/03/2002SE |
| K982652 | Allegiance Porta-Warm MattressIMD · Traditional | Allegiance Healthcare Corp. | 01/21/1999SE |
| K980509 | Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional | Deroyal Industries, Inc. | 02/26/1998SE |
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | Consolidated Products & Services, Inc. | 11/19/1997SE |
| K973770 | Allegiance Kwik Heat Warm Perineal PackIMD · Traditional | Allegiance Healthcare Corp. | 11/13/1997SE |
More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K925659 | U.C.E.Z. Lens Cleaner KitOCT · Traditional | 09/17/1993SE |
| K930161 | Anago Spinal Anesthesia TrayCAZ · Traditional | 07/06/1993SEKD |
| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926137 | Anago Fem-Cool/Fem-Cool PetiteIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
| K904276 | Disposable Beard CoverFXY · Traditional | 11/21/1990SE |
Questions and answers
When was Anago Warm Pack cleared by the FDA?
Anago Warm Pack (K926589) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 170 days after the submission was received.
What is the product code of K926589?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.