Stericover
510(k) K853044
Stericover is a Class II device made by Sterimed, Inc., cleared under FDA 510(k) K853044 on 1 Nov 1985, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853044 | Date1 Nov 1985 | StatusActive |
Official records
- FDA 510(k) database K853044
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZI
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1600
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K853044
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sterimed 0120 | 0120 | 00850341007004 | — | On the market |
| Sterimed 0141B | 0141B | 00850341007660 | — | On the market |
| Sterimed 0184 | 0184 | 00850341007059 | — | On the market |
| Sterimed 0184B | 0184B | 00850341007677 | — | On the market |
| Sterimed 0284 | 0284 | 00867878000408 | — | On the market |
| Sterimed 0284-2 | 0284-2 | 00867878000415 | — | On the market |
| Sterimed 0585 | 0585 | 00850341007080 | — | On the market |
| Sterimed 0585B | 0585B | 00850341007707 | — | On the market |
| Sterimed 0587W-1 | 0587W-1 | 00850341007851 | — | On the market |
| Sterimed 0785 | 0785 | 00850341007134 | — | On the market |
| Sterimed 0786 | 0786 | 00850341007141 | — | On the market |
| Sterimed 0886 | 0886 | 00850341007158 | — | On the market |
| Sterimed 0886B | 0886B | 00850341007615 | — | On the market |
| Sterimed 0888 | 0888 | 00850341007165 | — | On the market |
| Sterimed 0914 | 0914 | 00850341007172 | — | On the market |
| Sterimed 2023 | 2023 | 00850341007202 | — | On the market |
| Sterimed 3520SB | 3520SB | 00860001790214 | — | On the market |
| Sterimed 4065 | 4065 | 00850341007226 | — | On the market |
| Sterimed 4065X | 4065X | 00867878000477 | — | On the market |
| Sterimed 4425 | 4425 | 00850341007240 | — | On the market |
| Sterimed 4425B | 4425B | 00850341007714 | — | On the market |
| Sterimed 4440B | 4440B | 00850341007721 | — | On the market |
| Sterimed 4440T | 4440T | 00850341007264 | — | On the market |
| Sterimed 4456S | 4456S | 00850341007288 | — | On the market |
| Sterimed 4480B | 4480B | 00860007655609 | — | On the market |
| Sterimed 4480SB | 4480SB | 00850341007622 | — | On the market |
| Sterimed 4480W | 4480W | 00850341007301 | — | On the market |
| Sterimed 5380W | 5380W | 00850341007318 | — | On the market |
| Sterimed A0307 | A0307 | 00850341007950 | — | On the market |
| Sterimed AR1096-2 | AR1096-2 | 00850341007325 | — | On the market |
| Sterimed MG0056 | MG0056 | 00867878000460 | — | On the market |
| Sterimed MG0105 | MG0105 | 00850341007363 | — | On the market |
| Sterimed MR0150 | MR0150 | 00850341007752 | — | On the market |
| Sterimed PC0512 | PC0512 | 00850341007974 | — | On the market |
| Sterimed PC0548 | PC0548 | 00850341007400 | — | On the market |
| Sterimed PC0548CS | PC0548CS | 00850341007769 | — | On the market |
| Sterimed PC0596 | PC0596 | 00850341007417 | — | On the market |
| Sterimed PC0796 | PC0796 | 00850341007424 | — | On the market |
| Sterimed RC0596 | RC0596 | 00850341007448 | — | On the market |
| Sterimed RC0996 | RC0996 | 00850341007462 | — | On the market |
| Sterimed TR0105B | TR0105B | 00850341007776 | — | On the market |
| Sterimed VC0596 | VC0596 | 00850341007530 | — | On the market |
| Sterimed VC0596P | VC0596P | 00850341007547 | — | On the market |
| Sterimed VC0796 | VC0796 | 00850341007820 | — | On the market |
| Sterimed VC0796C | VC0796C | 00850341007837 | — | On the market |
| Sterimed VC0980P | VC0980P | 00850341007561 | — | On the market |
| Sterimed WR1010 | WR1010 | 00850341007509 | — | On the market |
| Sterimed ZB0096 | ZB0096 | 00850341007790 | — | On the market |
| Sterimed ZG1006 | ZG1006 | 00850341007813 | — | On the market |
| Sterimed ZG1007 | ZG1007 | 00850341007905 | — | On the market |
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