B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) (Delaware): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific). Its amount of 266 is above the median of 138 (86th percentile). Dated 13 days ago, it is in the active follow-up window. Score 67/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 266 · 86th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 13 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260302 |
| Device | B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC |
| Applicant | B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) |
| Specialty / panel | Microbiology |
| Product code | SJQ |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-30 |
| Decision date | 2026-10-23 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Hennigsdorf, DE |
| amount percentile | 86th of 414 (median 138, 1.9x median) |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)'s amount: 86th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 266-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 13 days ago.
What is the FDAPulse record for B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) in Delaware?
B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) by B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) was cleared on 2026-10-23 after 266 days of review.
How does B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) compare to other Delaware FDAPulse records?
Its amount of 266 sits in the upper half (86th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
| Elecsys EBV IgM (K260233) | IN | 2026-10-02 |
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