BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company
BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company (Maryland): 510(k) cleared for Becton Dickinson and Company. Its amount of 80 is below the median of 138 (23rd percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. 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: 80 · 23th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 4 related MD FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262163 |
| Device | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth |
| Applicant | Becton Dickinson and Company |
| Specialty / panel | Microbiology |
| Product code | JTZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-26 |
| Decision date | 2026-09-14 |
| Review time (days) | 80 |
| Third-party review | No |
| Applicant location | Sparks, MD, US |
| amount percentile | 23th of 414 (median 138, 0.6x median) |
| Peer records CSV (5 MD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MD first): Oncomine Dx Express Test (K260827) · CraniUS Plate (K262874) · Class II recall Z-0139-2027 · Class II recall Z-0140-2027 · SmartIPL_NI System (K241973) · 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: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company and 5 Maryland peers
- Maryland FDAPulse records like this one: 5
- BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company's amount: 23rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Maryland peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 80-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company in Maryland?
BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163) by Becton Dickinson and Company was cleared on 2026-09-14 after 80 days of review.
How does BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company compare to other Maryland FDAPulse records?
Its amount of 80 is below the median (23th percentile); smaller records often move faster and face less competition. It is 51 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163) | MD | 2026-09-14 |
| 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 |
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