ORACLE ORAL MASK, MODEL HC451A
FDA 510(k) clearance K033087 · decided 2004-01-14
Clearance details
- K-number
- K033087
- Device name
- ORACLE ORAL MASK, MODEL HC451A
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2004-01-14
- Days to decision
- 107 days
- Clearance type
- Special
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Tamaki, Auckland, NZ
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fisher & Paykel Healthcare
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| Orion (K253553) | Resmed Corp | 2026-06-04 |
| ResScan Essentials (K254104) | Resmed Corp | 2026-05-27 |
| Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (K251920) | Dcstar, Inc. | 2026-05-21 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| SleepRes PAP System (K251770) | Sleepres, Inc. | 2025-12-15 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431 recall (Z-0969-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. recall (Z-0970-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC40 recall (Z-0971-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. recall (Z-0972-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC45 recall (Z-0973-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuse recall (Z-0974-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |