Northstar Healthcare Holdings: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Northstar Healthcare Holdings” (first 2012, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 49 |
| 2013 | 2 | 149 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Northstar Healthcare Holdings 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122727 | BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE | LZA | 2013-02-22 | 170 |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O | LYY | 2013-01-17 | 128 |
| K123026 | TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO | LYY | 2012-11-16 | 49 |
| K122998 | BLUE POWDERED NITRILE EXAMINATION GLOVE | LZA | 2012-11-06 | 40 |
| K121926 | BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM | LZC | 2012-09-20 | 80 |
| K121947 | ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES | LZA | 2012-09-10 | 69 |
| K121529 | BLACK NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | 2012-07-12 | 49 |
| K121464 | BLUE POWER FREE NITRILE EXAMINATION GLOVE | LZA | 2012-07-05 | 49 |
| K121506 | UTB BLUE POWDER FREE NITRILE | LZA | 2012-07-03 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Northstar Healthcare Holdings.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Northstar Healthcare Holdings Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Northstar Healthcare Holdings?
FDA lists 9 510(k) clearances under the applicant name “Northstar Healthcare Holdings” (first 2012, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Northstar Healthcare Holdings?
The median time from FDA receipt to decision across 510(k)s cleared under the name Northstar Healthcare Holdings is 49 days.
Which FDA product codes appear under Northstar Healthcare Holdings?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 2); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 9 Northstar Healthcare Holdings clearances with predicates and recalls
- Run predicate analysis for product code LZA, Northstar Healthcare Holdings's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.