Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.
Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.: 510(k) cleared for Oxytek Medical Technology Co., Ltd. Its amount of 266 is above the median of 138 (86th percentile). Dated 42 days ago, it serves as a historical benchmark. 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: 266 · 86th 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 | K254289 |
| Device | Portable Oxygen Concentrator (OX-1A-E, OX-1B) |
| Applicant | Oxytek Medical Technology Co., Ltd. |
| Specialty / panel | Anesthesiology |
| Product code | CAW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-31 |
| Decision date | 2026-09-23 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Chencun Town, Shunde District, Foshan, CN |
| amount percentile | 86th of 414 (median 138, 1.9x median) |
| Peer records CSV (76 CN 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: 2026-09-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · 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: Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.'s amount: 86th 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)
61 / 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 42 days ago.
What is the FDAPulse record for Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.?
Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) by Oxytek Medical Technology Co., Ltd. was cleared on 2026-09-23 after 266 days of review.
How does Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 266 sits in the upper half (86th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window.
Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) | CN | 2026-09-23 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) | CN | 2026-09-18 |
| Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254) | CN | 2026-10-16 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
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