Cypress Medical Products, Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Cypress Medical Products, Ltd.” (first 1989, latest 2002), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 59 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| LYZ | Vinyl Patient Examination Glove | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 1 | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
Plus 8 more product codes.
Review panels
- General Hospital (12)
- General and Plastic Surgery (7)
- Gastroenterology and Urology (4)
- Cardiovascular (2)
- Obstetrics and Gynecology (1)
Most recent Cypress Medical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | HIB | 2002-07-12 | 52 |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | LYZ | 2001-08-06 | 17 |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | DXQ | 1998-07-07 | 335 |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | FXX | 1998-05-28 | 300 |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | FXX | 1998-02-26 | 205 |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | LYY | 1995-07-05 | 55 |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | LYY | 1995-03-31 | 67 |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | FCM | 1995-02-27 | 47 |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | FCM | 1995-02-27 | 48 |
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | LDE | 1994-12-08 | 52 |
16 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2004-12-02.
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.
- Cypress Medical Mfg., Inc. (2 510(k)s)
- Cypress Ent. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cypress Medical Products, Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Cypress Medical Products, Ltd.” (first 1989, latest 2002), across 18 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cypress Medical Products, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cypress Medical Products, Ltd. is 59 days.
Which FDA product codes appear under Cypress Medical Products, Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 3); LYZ (Vinyl Patient Examination Glove, 3); EFQ (Gauze/Sponge, Internal, 2).
Next steps
- See all 26 Cypress Medical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Cypress Medical Products, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.