Instrument Warmer
FDA 510(k) K925530 · Superior Healthcare Group, Inc.
510(k) numberK925530
Submission
- Device name
- Instrument Warmer
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- November 2, 1992
- Decision date
- June 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMS – Bed, Pediatric Open Hospital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5140
- Specialty
- General Hospital
Other 510(k)s with product code FMS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970334 | Nature's CradleFMS · Traditional | Infant Advantage, Inc. | 04/25/1997SE |
| K963210 | Vail 100 Pediatric CribFMS · Traditional | Vail Products, Inc. | 11/13/1996SE |
| K960747 | Nature's Cradle Model C1500FMS · Traditional | Infant Advantage, Inc. | 05/22/1996SE |
| K960012 | Stryker Adel BassinetFMS · Traditional | Stryker Corp. | 03/25/1996SE |
| K951024 | Nature's CradleFMS · Traditional | Infant Advantage, Inc. | 06/05/1995SE |
| K950059 | MC Infant Care Unie #PP30FMS · Traditional | Janco Consulting Services | 02/10/1995SE |
| K950058 | MC Healthcare #CH31 Child's CribFMS · Traditional | Janco Consulting Services | 02/10/1995SE |
| K950051 | Brewer Company Teddy Crib Model 71900-A, B, 71910-A, BFMS · Traditional | The Brewer Co. | 02/10/1995SE |
| K925949 | Pedicragt BassinetFMS · Traditional | Pedicraft, Inc. | 04/20/1993SE |
| K925817 | Head & Foot End Drop Pedi-CribFMS · Traditional | Pedicraft, Inc. | 04/20/1993SE |
More from Pedicraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | 03/15/1993SE |
| K905755 | Non-Sterile Patient Examination GlovesLYY · Traditional | 03/08/1991SE |
| K903347 | Sodium Chloride SolutionFOZ · Traditional | 12/13/1990SE |
| K904216 | Sterile Water Solution Catalog # 10000JOL · Traditional | 11/16/1990SE |
| K903340 | Sterile Urethral Catheter Procedure KitsFCM · Traditional | 10/04/1990SESD |
| K896321 | No. 34100 - 8 FR & No. 34400 - 14 FR Closed Trach.BSY · Traditional | 11/13/1989SE |
| K894676 | Sterile Latex Exam GlovesLYY · Traditional | 08/17/1989SE |
| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | 06/22/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was Instrument Warmer cleared by the FDA?
Instrument Warmer (K925530) received a 510(k) decision of Substantially Equivalent on June 18, 1993, 228 days after the submission was received.
What is the product code of K925530?
The FDA product code is FMS – Bed, Pediatric Open Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5140.