BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company (New Jersey): 510(k) cleared for Becton, Dickinson and Company. Its amount of 445 is top-decile (99th percentile of 414 records). Dated 19 days ago, it is in the active follow-up window. Score 61/100. As of 2026-11-03, 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: 445 · 99th percentile of 414 FDAPulse records · 3.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 17 related NJ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K252344 |
| Device | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) |
| Applicant | Becton, Dickinson and Company |
| Specialty / panel | Clinical Chemistry |
| Product code | JKA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-07-28 |
| Decision date | 2026-10-16 |
| Review time (days) | 445 |
| Third-party review | No |
| Applicant location | Franklin Lakes, NJ, US |
| amount percentile | 99th of 414 (median 138, 3.2x median) |
| Peer records CSV (18 NJ 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: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (NJ first): STA® - Liquid Anti-Xa (K260214) · Class II recall Z-0164-2027 · Class II recall Z-0166-2027 · Class II recall Z-0165-2027 · Class II recall Z-0167-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company and 18 New Jersey peers
- New Jersey FDAPulse records like this one: 18
- BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company's amount: 99th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New Jersey peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 445-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 19 days ago.
What is the FDAPulse record for BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company in New Jersey?
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) by Becton, Dickinson and Company was cleared on 2026-10-16 after 445 days of review.
How does BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company compare to other New Jersey FDAPulse records?
This is a top-decile record: its amount of 445 is 3.2x the median of 138 across 414 records. It is 19 days old, still within a typical 45-day follow-up window.
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
| Mint ACE Pump (K260001) | CA | 2026-09-11 |
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