Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Niic U.S.A., Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
166 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902133 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1990-10-02 | 145 | 0 |
| K901205 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) | Niic U.S.A., Inc. | 1990-08-14 | 153 | 0 |
| K902063 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1990-06-29 | 57 | 0 |
| K901204 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS | Niic U.S.A., Inc. | 1990-06-05 | 83 | 0 |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | 1990-05-24 | 128 | 0 |
| K896988 | NIIC LASER SYSTEM | Niic U.S.A., Inc. | 1990-01-23 | 49 | 0 |
| K895581 | MODEL: IR205 ARTICULATED SURGICAL LASER | Niic U.S.A., Inc. | 1989-12-13 | 89 | 0 |
| K895247 | MODEL IR103 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-11-16 | 87 | 0 |
| K892359 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-11-16 | 224 | 0 |
| K895239 | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER | Niic U.S.A., Inc. | 1989-11-16 | 87 | 0 |
| K894074 | CO2 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-08-24 | 77 | 0 |
| K882951 | CO2 SURGICAL LASER SYSTEM MODEL #IR105 | Niic U.S.A., Inc. | 1988-11-02 | 111 | 0 |
| K882952 | CO2 SURGICAL LASER SYSTEM MODEL #IR106 | Niic U.S.A., Inc. | 1988-11-02 | 111 | 0 |
| K880816 | MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1988-08-01 | 166 | 0 |
| K880815 | DX101-T ULTRASONIC SURGICAL SYSTEM | Niic U.S.A., Inc. | 1988-04-13 | 56 | 0 |
| K880814 | DX101 ULTRASONIC SURGICAL SYSTEM | Niic U.S.A., Inc. | 1988-04-13 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda