Instrument Makar, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Instrument Makar, Inc.” (first 1979, latest 2000), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| JOS | Electrode, Electrosurgical | 2 | 2 |
| KYZ | Syringe, Irrigating (Non Dental) | 2 | 2 |
| LYU | Accessory, Surgical Apparel | 2 | 2 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| GCS | Endoscope, Battery-Powered And Accessories | 1 | 1 |
| GDF | Guide, Needle, Surgical | 1 | 1 |
Plus 10 more product codes.
Review panels
Most recent Instrument Makar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002600 | LITWIN CRUICATE ANCHOR | MBI | 2000-11-15 | 86 |
| K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT | JWH | 1998-11-06 | 233 |
| K963396 | BIOSPHERE SUTURE ANCHOR | MAI | 1997-05-06 | 251 |
| K964364 | DISPOSABLE APRON | LYU | 1997-02-25 | 116 |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | FXP | 1996-11-19 | 329 |
| K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR | MAI | 1996-07-09 | 151 |
| K943249 | BIOABSORBABLE INTERFERENCE SCREW | MAI | 1995-07-31 | 390 |
| K944062 | LAPRASCOPIC GRASPER | GCS | 1995-02-23 | 188 |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | LYU | 1995-02-23 | 254 |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | HWC | 1994-02-10 | 350 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Instrument Makar, Inc..
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.
- Instrument Technology, Inc. (2 510(k)s)
- Instrument AB Scanditronix (1 510(k)s)
- Instrument Development Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instrument Makar, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Instrument Makar, Inc.” (first 1979, latest 2000), across 20 product codes in 4 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 Instrument Makar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instrument Makar, Inc. is 82 days.
Which FDA product codes appear under Instrument Makar, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 3); JDR (Staple, Fixation, Bone, 2).
Next steps
- See all 28 Instrument Makar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Instrument Makar, 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.