Busse Hospital Disposables, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Busse Hospital Disposables, Inc.” (first 1983, latest 2015), across 25 product codes in 6 review panels. Median 510(k) review time under this name: 79 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 | 1 | 175 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 279 |
| 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| KNW | Instrument, Biopsy | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| HFW | Clamp, Umbilical | 2 | 2 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
Plus 15 more product codes.
Review panels
- General Hospital (12)
- General and Plastic Surgery (9)
- Anesthesiology (8)
- Obstetrics and Gynecology (3)
- Gastroenterology and Urology (1)
- Pathology (1)
Most recent Busse Hospital Disposables, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141285 | BUSSE EXTENSION SET | FPA | 2015-02-19 | 279 |
| K120002 | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | KNW | 2012-06-26 | 175 |
| K110883 | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA | KNW | 2011-06-08 | 70 |
| K093920 | BUSSE EPIDURAL CATHETER KIT | BSO | 2010-08-06 | 227 |
| K093909 | BUSSE SURGICAL DRAPES IV | KKX | 2010-05-06 | 135 |
| K092212 | BUSSE SURGICAL DRAPES III | KKX | 2009-10-09 | 79 |
| K082297 | BUSSE SURGICAL DRAPE | KKX | 2008-12-09 | 119 |
| K073222 | MODIFICATION TO:SPECIALTY NEEDLES | BSP | 2008-04-09 | 146 |
| K070465 | BUSSE EPIDURAL CATHETER | BSO | 2007-07-19 | 153 |
| K063018 | GLASS LOSS OF RESISTANCE SYRINGE | CAZ | 2007-01-22 | 112 |
25 earlier clearances. See the full list in Caduvo.
Recalls
66 product recalls in 4 recall events; 63 initiated in the last five years. Most recent: 2023-11-30.
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.
- Busse Hosipital Disposables (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Busse Hospital Disposables, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Busse Hospital Disposables, Inc.” (first 1983, latest 2015), across 25 product codes in 6 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 Busse Hospital Disposables, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Busse Hospital Disposables, Inc. is 79 days.
Which FDA product codes appear under Busse Hospital Disposables, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 4); KNW (Instrument, Biopsy, 3); BSO (Catheter, Conduction, Anesthetic, 2).
Next steps
- See all 35 Busse Hospital Disposables, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Busse Hospital Disposables, Inc.'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.