FDA product code NKX: Needle, Phacoemulsification, Reprocessed
NKX is the FDA product code for needle, phacoemulsification, reprocessed. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under NKX, from 5 different applicants. The average 510(k) review took 152 days (median 91). FDA has posted 11 recalls for NKX devices.
Definition
Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Phacoemulsification, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 886.4670 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NKX clearance
Top NKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alliance Medical Corp. | 1 | 2007-03-19 |
| Alliance Medical, Inc. | 1 | 2005-09-23 |
| Surgical Instruments Service and Savings, Inc. | 1 | 2003-01-24 |
| Vanguard Medical Concepts, Inc. | 1 | 2001-11-09 |
| Sterilmed, Inc. | 1 | 2001-11-08 |
Most recent NKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060648 | Alliance Medical Corp. | REPROCESSED PHACOEMULSIFICATION TIPS | 2007-03-19 | 371 |
| K050518 | Alliance Medical, Inc. | REPROCESSED PHACOEMUISIFICATION TIPS | 2005-09-23 | 206 |
| K030179 | Surgical Instruments Service and Savings, Inc. | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | 2003-01-24 | 7 |
| K012698 | Vanguard Medical Concepts, Inc. | VANGUARD REPROCESSED PHACOEMULSIFICATION | 2001-11-09 | 87 |
| K012579 | Sterilmed, Inc. | REPROCESSED PHACO TIPS | 2001-11-08 | 91 |
Recalls for NKX devices
11 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-03.
Frequently asked questions
What is FDA product code NKX?
NKX is the FDA product code for needle, phacoemulsification, reprocessed. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel.
What device class is NKX?
Class II, regulation 21 CFR 886.4670. Typical premarket route: 510(k).
How long does a 510(k) take for product code NKX?
Across 5 cleared submissions the average was 152 days from receipt to decision (median 91).
Which companies have the most NKX clearances?
Alliance Medical Corp. (1); Alliance Medical, Inc. (1); Surgical Instruments Service and Savings, Inc. (1); Vanguard Medical Concepts, Inc. (1); Sterilmed, Inc. (1).
Have NKX devices been recalled?
Yes: 11 product recalls across 3 recall events; the most recent began 2013-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NKX
- Run a recall and safety report across every NKX manufacturer
- Watch product code NKX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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