KOI(TM) BLADE GAUGE, MODEL KOI-132
FDA 510(k) clearance K881094 · decided 1988-04-01
Clearance details
- K-number
- K881094
- Device name
- KOI(TM) BLADE GAUGE, MODEL KOI-132
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-15
- Decision date
- 1988-04-01
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- HOE
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CALIPER-OPTHALMIC (K813315) | Design Research Assoc., Inc. | 1982-03-01 |
| KREMER BLADE GAUGE (K820050) | Accutome, Inc. | 1982-02-24 |
| BLADE GAUGE (K812011) | Koi, Inc. | 1981-07-28 |
| BLEPHAROMETER (K801937) | Aztec Medical Products, Inc. | 1980-09-16 |
| KELMAN DIPSTICK (K792383) | V. Mueller O.V. Baxter Healthcare Corp. | 1979-12-11 |
| RULER, WECK SCOTT (K781715) | Edward Weck, Inc. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |