Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254171

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.

Q: How to monitor Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. and peer anesthesiology records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.: 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 48 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K254171
Device	Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
Applicant	Shenzhen Mericonn Technology Co., Ltd.
Specialty / panel	Anesthesiology
Product code	CAF
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-23
Decision date	2026-09-18
Review time (days)	269
Third-party review	No
Applicant location	Shenzhen, CN
amount percentile	93th 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: 2026-09-18
Data refreshed: 2026-11-04
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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: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. and 76 CN peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

CN FDAPulse records like this one: 76
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.'s amount: 93rd percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

55 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.

What is the FDAPulse record for Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.?

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) by Shenzhen Mericonn Technology Co., Ltd. was cleared on 2026-09-18 after 269 days of review.

How does Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. compare to other FDAPulse records?

This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 48 days old; check the official source for later updates before acting.

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) vs. top 3 peers

Organization	Location	Record date
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171)	CN	2026-09-18
BreathCare PAP III (YH-390N) (K260251)	CN	2026-10-23
Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289)	CN	2026-09-23
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254)	CN	2026-10-16

How to monitor Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. and peer anesthesiology records

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