FDA product code HAO: Instrument, Surgical, Non-Powered
HAO is the FDA product code for instrument, surgical, non-powered. It is a Class I device, regulated under 21 CFR 882.4535 and reviewed by the Neurology panel. FDA has cleared 34 510(k) submissions under HAO, 1 in the last five years, from 18 different applicants. The average 510(k) review took 47 days (median 25). FDA has posted 2 recalls for HAO devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Non-Powered |
| Device class | Class I |
| Regulation | 21 CFR 882.4535 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for HAO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 161 |
Compare with all 510(k) review times · Search every HAO clearance
Top HAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 7 | 1995-05-18 |
| Downs Surgical , Ltd. | 5 | 1988-02-11 |
| Edward Weck, Inc. | 3 | 1978-05-16 |
| Acra Cut, Inc. | 2 | 1991-02-12 |
| Cedar Surgical, Inc. | 2 | 1986-09-24 |
13 more applicants have HAO clearances. See the full list in Caduvo.
Most recent HAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220920 | Shenzhen Shineyard Medical Device Co. , Ltd. | Matreneu Percutaneous Balloon Compression Kit | 2022-09-07 | 161 |
| K940973 | Cook, Inc. | MULLAN GANGLION MICROCOMPRESSION SET | 1995-09-29 | 575 |
| K951492 | United States Surgical, A Division of Tyco Healthc | RIB RESECTOR | 1995-05-18 | 48 |
| K943115 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE PITUITARY SPINAL RONGEUR | 1994-07-25 | 28 |
| K942971 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE SPINAL DISSECTOR | 1994-07-20 | 30 |
Recalls for HAO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-04-04.
Frequently asked questions
What is FDA product code HAO?
HAO is the FDA product code for instrument, surgical, non-powered. It is a Class I device, regulated under 21 CFR 882.4535 and reviewed by the Neurology panel.
What device class is HAO?
Class I, regulation 21 CFR 882.4535. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HAO?
Across 34 cleared submissions the average was 47 days from receipt to decision (median 25).
Which companies have the most HAO clearances?
United States Surgical, A Division of Tyco Healthc (7); Downs Surgical , Ltd. (5); Edward Weck, Inc. (3); Acra Cut, Inc. (2); Cedar Surgical, Inc. (2).
Have HAO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code HAO
- Run a recall and safety report across every HAO manufacturer
- Watch product code HAO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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