Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.
Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. (California): 510(k) cleared for Carecubes, Inc. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 20 days ago, it is in the active follow-up window. Score 61/100. 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: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260180 |
| Device | Carecube Negative Pressure Isolation Chamber (1BY) |
| Applicant | Carecubes, Inc. |
| Specialty / panel | General Hospital |
| Product code | LGM |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-21 |
| Decision date | 2026-10-16 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | San Francisco, CA, US |
| amount percentile | 90th 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: 2026-10-16
- Data refreshed: 2026-11-04
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Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · 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: Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.'s amount: 90th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 20 days ago.
What is the FDAPulse record for Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. in California?
Carecube Negative Pressure Isolation Chamber (1BY) (K260180) by Carecubes, Inc. was cleared on 2026-10-16 after 268 days of review.
How does Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. compare to other California FDAPulse records?
This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 20 days old, still within a typical 45-day follow-up window.
Carecube Negative Pressure Isolation Chamber (1BY) (K260180) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) | PA | 2026-10-09 |
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